![A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) LOTION [ORIGINS NATURAL RESOURCES INC]](https://medic.hrt.org//dailymed/images/f73a4044-d67e-4038-9710-49f569d0777f/a-perfect-01.jpg)
| NDC | 59427-706-01, 59427-706-02 |
| Set ID | f73a4044-d67e-4038-9710-49f569d0777f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ORIGINS NATURAL RESOURCES INC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
For sunscreen use:
- apply generously and evenly 15 minutes before sun exposure
- reapply at least every two hours
- use a water resistant sunscreen if swimming or sweating
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am – 2pm
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
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Inactive ingredients
water\aqua\eau; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water • butyloctyl salicylate • methyl trimethicone • jojoba esters • polyester-8 • ethyl macadamiate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • butylene glycol • peg-100 stearate • glyceryl stearate • citrus aurantium bergamia (bergamot) fruit oil1, citrus medica limonum (lemon) peel oil1, citrus aurantium dulcis (orange) oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida (orris) root extract, rosa damascena (rose) extract, citral, linalool, limonene • camellia sinensis (white tea) leaf extract • pinus pinaster bark/bud extract • arabidopsis thaliana extract • ascorbyl tocopheryl maleate • oryzanol • ergothioneine • triticum vulgare (wheat) germ extract • laminaria saccharina extract • mangifera indica (mango) seed butter • butyrospermum parkii (shea butter) • potassium cetyl phosphate • caffeine • cholesterol • linoleic acid • hordeum vulgare (barley) extract\extrait d'orge • cetyl alcohol • ethylhexylglycerin • trioctyldodecyl citrate • lecithin • squalane • dehydroxanthan gum • caprylyl glycol • sodium hyaluronate • ammonium acryloyldimethyltaurate/vp copolymer • silica • sodium stearate • citric acid • sodium dehydroacetate • phenoxyethanol • mica • iron oxides (ci 77491, ci 77492, ci 77499) <iln36397>
- 1
- essential oil
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
A PERFECT WORLD SPF 35 UV BROAD SPECTRUM FACE PROTECTOR
homosalate, octisalate, avobenzone, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-706 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.7 mL in 100 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) citrus aurantium flower oil (UNII: D4BGE91OXH) chamaemelum nobile flower oil (UNII: UB27587839) butyloctyl salicylate (UNII: 2EH13UN8D3) methyl trimethicone (UNII: S73ZQI0GXM) ethyl macadamiate (UNII: ANA2NCS6V1) butylene glycol (UNII: 3XUS85K0RA) peg-100 stearate (UNII: YD01N1999R) glyceryl monostearate (UNII: 230OU9XXE4) bergamot oil (UNII: 39W1PKE3JI) lemon oil (UNII: I9GRO824LL) orange oil (UNII: AKN3KSD11B) camphor oil (UNII: 75IZZ8Y727) spearmint oil (UNII: C3M81465G5) magnolia acuminata flower (UNII: 8LCB7ZW9UL) iris pallida root (UNII: LVV57EM5OG) rosa damascena flower (UNII: JWB78P295A) citral (UNII: T7EU0O9VPP) linalool, (+/-)- (UNII: D81QY6I88E) maritime pine (UNII: 50JZ5Z98QY) gamma oryzanol (UNII: SST9XCL51M) ergothioneine (UNII: BDZ3DQM98W) wheat germ (UNII: YR3G369F5A) saccharina latissima thallus (UNII: 68CMP2MB55) mangifera indica seed butter (UNII: 4OXD9M35X2) shea butter (UNII: K49155WL9Y) potassium cetyl phosphate (UNII: 03KCY6P7UT) caffeine (UNII: 3G6A5W338E) cholesterol (UNII: 97C5T2UQ7J) linoleic acid (UNII: 9KJL21T0QJ) cetyl alcohol (UNII: 936JST6JCN) ethylhexylglycerin (UNII: 147D247K3P) squalane (UNII: GW89575KF9) caprylyl glycol (UNII: 00YIU5438U) hyaluronate sodium (UNII: YSE9PPT4TH) ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG) silicon dioxide (UNII: ETJ7Z6XBU4) sodium stearate (UNII: QU7E2XA9TG) citric acid monohydrate (UNII: 2968PHW8QP) sodium dehydroacetate (UNII: 8W46YN971G) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-706-01 1 in 1 CARTON 1 NDC:59427-706-02 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2010 Labeler - ORIGINS NATURAL RESOURCES INC (611716283) Establishment Name Address ID/FEI Business Operations ELGC K.K. 712808195 RELABEL(59427-706) , REPACK(59427-706) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706) Establishment Name Address ID/FEI Business Operations Estee Lauder Inc. 042918826 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-706) , RELABEL(59427-706) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 943871157 MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 959338336 MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 949264774 MANUFACTURE(59427-706) , RELABEL(59427-706) , REPACK(59427-706) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59427-706) Establishment Name Address ID/FEI Business Operations Pennsylvania Logistics Center 078364654 REPACK(59427-706) , RELABEL(59427-706)
