Label: A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA- octisalate, avobenzone, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 59427-702-01, 59427-702-02 - Packager: ORIGINS NATURAL RESOURCES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 1, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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; citrus aurantium amara (bitter orange) flower water, anthemis nobilis (chamomile) flower water ∙ butyloctyl salicylate ∙ ethyl macadamiate ∙ methyl trimethicone jojoba esters ∙ butylene glycol ∙ lauryl peg-9 polydimethylsiloxyethyl dimethicone ∙ 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 ∙ hordeum vulgare (barley) extract ∙ cholesterol ∙ caffeine ∙ mangifera indica (mango) seed butter ∙ butyrospermum parkii (shea butter) ∙ potassium cetyl phosphate ∙ cetyl alcohol ∙ ethylhexylglycerin ∙ linoleic acid ∙ squalane ∙ sodium hyaluronate ∙ caprylyl glycol ∙ dehydroxanthan gum ∙ silica ∙ ammonium acryloyldimethyltaurate/vp copolymer ∙ citric acid ∙ sodium stearate ∙ sodium dehydroacetate ∙ phenoxyethanol ∙ mica <iln36381>
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- essential oil
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton
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INGREDIENTS AND APPEARANCE
A PERFECT WORLD SPF 25 AGE DEFENSE MOISTURIZER WITH WHITE TEA
octisalate, avobenzone, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59427-702 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 FRUIT (UNII: DQD16J2B5O) CHAMOMILE (UNII: FGL3685T2X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) 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) BARLEY (UNII: 5PWM7YLI7R) CHOLESTEROL (UNII: 97C5T2UQ7J) CAFFEINE (UNII: 3G6A5W338E) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) SHEA BUTTER (UNII: K49155WL9Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LINOLEIC ACID (UNII: 9KJL21T0QJ) SQUALANE (UNII: GW89575KF9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM STEARATE (UNII: QU7E2XA9TG) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59427-702-01 1 in 1 CARTON 1 NDC:59427-702-02 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 12/01/2010 Labeler - ORIGINS NATURAL RESOURCES INC (611716283) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL(59427-702) , REPACK(59427-702) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(59427-702) , RELABEL(59427-702) , REPACK(59427-702) Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 REPACK(59427-702) , RELABEL(59427-702) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 787336577 MANUFACTURE(59427-702) , RELABEL(59427-702) , REPACK(59427-702) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 949264774 MANUFACTURE(59427-702) , REPACK(59427-702) , RELABEL(59427-702) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 618107429 MANUFACTURE(59427-702) , REPACK(59427-702) , RELABEL(59427-702) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(59427-702) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(59427-702)
