NDC | 63127-400-01 |
Set ID | d49acbca-c54e-422e-b9ab-c4db0de064e6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Luzern Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients:
- Purpose
- Active Ingredients:
- Purpose
- Uses:
- Warnings
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Directions
Apply liberally/generously (and evenly) 15 minutes before sun exposure; Reapply at least every 2 hours or after swimming, towel drying, perspiring heavily and washing; and For use on children less than 6 months of age, consult a health care practitioner.
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:
- •
- a. limit time in the sun, especially from 10 a.m. – 2 p.m.; and
- •
- b. wear long-sleeved shirts, pants, hats and sunglasses.
- •
- c. Reapply after 40 minutes of swimming or sweating; and
- •
- d. Reapply immediately after towel drying
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INACTIVE INGREDIENTS:
WATER (AQUA*†), CYCLOPENTASILOXANE†, CAPRYLIC/CAPRIC TRIGLYCERIDE*†, OCTYLDODECYL NEOPENTANOATE†, SILICA*†, PROPANEDIOL*†, ETHYLHEXYL ISONONANOATE*†, DIMETHICONE, STEARETH-21, METHYLCELLULOSE*†, HEXYLDECANOL*†, CETYL ALCOHOL*†, GLYCERIN**†, SODIUM ASCORBYL PHOSPHATE*†, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL**†, SODIUM HYALURONATE*†, PANTHENOL*†, SODIUM PCA*†, TOCOPHERYL ACETATE*†, TOCOPHERSOLAN†, ALGAE EXTRACT*†, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT**†, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT**†, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT**†, BUDDLEJA DAVIDII EXTRACT**†, LEONTOPDOIUM ALPINUM (EDELWEISS) EXTRACT**†, THYMUS VULGARIS (THYME) EXTRACT**†, TAGETES ERECTA (MARIGOLD) FLOWER EXTRACT*†, C14-22 ALCOHOLS*†, ISOSTEARYL PALMITATE*†, STEARETH-2*†, C12-20 ALKYL GLUCOSIDE*†, L-ARGININE*†, CARBOMER†, CUCUMIS SATIVUS (CUCUMBER) OIL*†, CITRIC ACID*†, TETRASODIUM GLUTAMATE DIACETATE*†, CAPRYLHYDROXAMIC ACID*†, GLYCERYL CAPRYLATE*†, ETHYLHEXYLGLYCERIN*†, GLYCERYL UNDECYLENATE*†, METHYLPROPANEDIOL*†, JOJOBA ESTERS*†, IRON OXIDES (CI 77492) *†, IRON OXIDES (CI 77491) *†, IRON OXIDES (CI 77499) *†.
*NATURAL-DERIVED / DÉRIVÉS DE NATUREL and/or ECOCERT
**CERTIFIED ORGANIC/CERTIFIÉ ORGANIQUE USDA/ECOCERT/BIO-SUISSE
†LOW HAZARD RATING OF “GREEN 0 – 2” (NON-TOXIC, NON-IRRITATING) - Principal Display Panel – Carton Label
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INGREDIENTS AND APPEARANCE
LA DEFENSE URBAN PROTECT MINERAL BB CREAM BROAD SPECTRUM SPF20, COOL UNDERTONE
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63127-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPANEDIOL (UNII: 5965N8W85T) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) DIMETHICONE (UNII: 92RU3N3Y1O) STEARETH-21 (UNII: 53J3F32P58) HEXYLDECANOL (UNII: 151Z7P1317) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SAFFLOWER OIL (UNII: 65UEH262IS) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PANTHENOL (UNII: WV9CM0O67Z) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHERSOLAN (UNII: O03S90U1F2) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GINGER (UNII: C5529G5JPQ) THYME (UNII: CW657OBU4N) C14-22 ALCOHOLS (UNII: B1K89384RJ) ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1) STEARETH-2 (UNII: V56DFE46J5) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) ARGININE (UNII: 94ZLA3W45F) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) METHYLPROPANEDIOL (UNII: N8F53B3R4R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63127-400-01 1 in 1 CARTON 09/20/2017 1 50 g 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 09/20/2017 Labeler - Luzern Laboratories, Inc. (188040476) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing, Inc. 793406000 MANUFACTURE(63127-400)