![A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ORIGINS NATURAL RESOURCES INC.]](https://medic.hrt.org//dailymed/images/c5c6799b-5d8c-4fbd-abb3-7a57dc3958ba/apw-01.jpg)
| NDC | 59427-011-01 |
| Set ID | c5c6799b-5d8c-4fbd-abb3-7a57dc3958ba |
| 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 • isocetyl stearoyl stearate • butylene glycol • c12-15 alkyl benzoate • cetyl alcohol • butyrospermum parkii (shea butter) • laureth-4 • dimethicone • trehalose • polyethylene • peg-100 stearate • cetyl esters • camellia sinensis (white tea) leaf extract • sigesbeckia orientalis (st. paul's wort) extract • vaccinium macrocarpon (cranberry) fruit extract • vaccinium angustifolium (blueberry) fruit extract • solanum tuberosum (potato) pulp extract • opuntia tuna extract • lycium chinense (wolfberry) fruit extract • eriobotrya japonica (loquat) leaf extract • molasses extract\saccharum officinarum\extrait de mélasse • betula alba (birch) bark extract • passiflora incarnata flower extract • lythrum salicaria extract • saccharomyces lysate extract • phytosphingosine • aminopropyl ascorbyl phosphate • leontopodium alpinum extract • algae extract • sodium hyaluronate • yeast extract\faex\extrait de levure • boswellia serrata extract • astrocaryum murumuru seed butter • ergothioneine • oryzanol • hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer • lauric acid • glycerin • squalane • tocopheryl acetate • isostearic acid • caprylyl glycol • polyhydroxystearic acid • polysorbate 60 • sodium pca • urea • sodium phytate • aluminum hydroxide • tromethamine • hexylene glycol • polyquaternium-51 • lecithin • bht • phenoxyethanol • mica • iron oxides (ci 77491, ci 77492, ci 77499) <iln42825>
- Other information
- PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton
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INGREDIENTS AND APPEARANCE
A PERFECT WORLD AGE DEFENSE EYE WITH WHITE TEA BROAD SPECTRUM SPF 20
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 61.56 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL ALCOHOL (UNII: 936JST6JCN) SHEA BUTTER (UNII: K49155WL9Y) LAURETH-4 (UNII: 6HQ855798J) DIMETHICONE (UNII: 92RU3N3Y1O) TREHALOSE (UNII: B8WCK70T7I) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PEG-100 STEARATE (UNII: YD01N1999R) CETYL ESTERS WAX (UNII: D072FFP9GU) WHITE TEA (UNII: O0M3396E09) CRANBERRY (UNII: 0MVO31Q3QS) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) POTATO PULP (UNII: 844I2DX0IS) LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q) ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11) MOLASSES (UNII: LSU3YX0KZO) BETULA PUBESCENS BARK (UNII: 3R504894L9) PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) ERGOTHIONEINE (UNII: BDZ3DQM98W) GAMMA ORYZANOL (UNII: SST9XCL51M) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) LAURIC ACID (UNII: 1160N9NU9U) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISOSTEARIC ACID (UNII: X33R8U0062) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYSORBATE 60 (UNII: CAL22UVI4M) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) UREA (UNII: 8W8T17847W) PHYTATE SODIUM (UNII: 88496G1ERL) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) TROMETHAMINE (UNII: 023C2WHX2V) HEXYLENE GLYCOL (UNII: KEH0A3F75J) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 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:59427-011-01 1 in 1 CARTON 06/01/2017 1 15 mL in 1 TUBE; 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(59427-011) , REPACK(59427-011) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 244669714 MANUFACTURE(59427-011) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 202952982 MANUFACTURE(59427-011) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-011) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-011) Establishment Name Address ID/FEI Business Operations NORTHTEC INC 943871157 RELABEL(59427-011) , REPACK(59427-011) Establishment Name Address ID/FEI Business Operations NORTHTEC LLC 959338336 MANUFACTURE(59427-011) Establishment Name Address ID/FEI Business Operations PADC 1 949264774 RELABEL(59427-011) , REPACK(59427-011) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-011) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(59427-011)
