![A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE) CREAM [ORIGINS NATURAL RESOURCES INC.]](https://medic.hrt.org//dailymed/images/abd8b302-a01c-478d-919a-22e686cb88da/apwspf-01.jpg)
| NDC | 59427-010-01 |
| Set ID | abd8b302-a01c-478d-919a-22e686cb88da |
| 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
-
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 • butylene glycol • glycerin • ammonium acryloyldimethyltaurate/vp copolymer • polyethylene • citrus aurantium bergamia (bergamot) fruit oil1, citrus limon (lemon) peel oil1, citrus aurantium dulcis (orange) oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida root extract, rosa damascena extract, citral, linalool, limonene • cetyl alcohol • glyceryl stearate • peg-100 stearate • peg-6 • vaccinium angustifolium (blueberry) fruit extract • vaccinium macrocarpon (cranberry) fruit extract • solanum tuberosum (potato) pulp extract • lycium chinense (wolfberry) fruit extract • eriobotrya japonica (loquat) leaf extract • passiflora incarnata flower extract • leontopodium alpinum extract • betula alba (birch) bark extract • camellia sinensis (white tea) leaf extract • boswellia serrata extract • sigesbeckia orientalis (st. paul's wort) extract • thermus thermophillus ferment • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • saccharomyces lysate extract • lythrum salicaria extract • yeast extract\faex\extrait de levure • algae extract • oryzanol • squalane • ethylhexylglycerin • trehalose • steareth-21 • ergothioneine • sodium hyaluronate • vp/eicosene copolymer • nylon-12 • caprylyl glycol • sodium pca • sodium dehydroacetate • tocopheryl acetate • urea • ascorbyl tocopheryl maleate • citric acid • polyquaternium-51 • hexylene glycol • lecithin • sodium phytate • bht • mica • phenoxyethanol <iln42821>
- 1
- essential oil
- Other information
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA
avobenzone, homosalate, octinoxate, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) 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) CITRAL (UNII: T7EU0O9VPP) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) CRANBERRY (UNII: 0MVO31Q3QS) POTATO PULP (UNII: 844I2DX0IS) LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q) ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11) PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) BETULA PUBESCENS BARK (UNII: 3R504894L9) WHITE TEA (UNII: O0M3396E09) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) THERMUS THERMOPHILUS LYSATE (UNII: 775R692494) HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q) WHEAT GERM (UNII: YR3G369F5A) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) GAMMA ORYZANOL (UNII: SST9XCL51M) SQUALANE (UNII: GW89575KF9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TREHALOSE (UNII: B8WCK70T7I) STEARETH-21 (UNII: 53J3F32P58) ERGOTHIONEINE (UNII: BDZ3DQM98W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) NYLON-12 (UNII: 446U8J075B) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UREA (UNII: 8W8T17847W) ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHYTATE SODIUM (UNII: 88496G1ERL) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MICA (UNII: V8A1AW0880) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-010-01 1 in 1 CARTON 06/01/2017 1 50 mL in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 06/01/2017 Labeler - ORIGINS NATURAL RESOURCES INC. (611716283) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COMPANY, THE 828534516 RELABEL(59427-010) , REPACK(59427-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(59427-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-010) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-010) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(59427-010) , REPACK(59427-010) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 959338336 MANUFACTURE(59427-010) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(59427-010) , REPACK(59427-010) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-010) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(59427-010)
