NDC | 63127-300-01, 63127-300-02 |
Set ID | 47662860-16d0-4a47-9741-bdfbfe6e09cc |
Category | HUMAN OTC DRUG LABEL |
Packager | Luzern Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients:
- Purpose
- Uses:
-
Warnings
For external use only
Avoid contact with eyes.
If contact occurs, rinse thoroughly with water. Do not use on damaged or broken skin. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner. If swallowed, get medical help or contact a Poison Control Center right away.
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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:
ALGAE EXTRACT*†, BUDDLEJA DAVIDII EXTRACT**†, C12-20 ALKYL GLUCOSIDE*†, C14-22 ALCOHOLS*†, CAPRYLHYDROXAMIC ACID*†, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT*†*, CAPRYLIC/CAPRIC TRIGLYCERIDE*†, CARBOMER†, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL**†, CETYL ALCOHOL*†, CITRIC ACID*†, CUCUMIS SATIVUS (CUCUMBER) OIL*†, CYCLOPENTASILOXANE*†, ETHYLHEXYL ISONONANOATE†, ETHYLHEXYLGLYCERIN*†, GLYCERIN**†, GLYCERYL CAPRYLATE*†, GLYCERYL UNDECYLENATE*†, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT**†, HEXYLDECANOL*†, ISOSTEARYL PALMITATE*†, L-ARGININE*†, LEONTOPDOIUM ALPINUM (EDELWEISS) EXTRACT**†, METHYLCELLULOSE*†, METHYLPROPANEDIOL*†, OCTYLDODECYL NEOPENTANOATE†, PANTHENOL*†, PROPANEDIOL*†, SODIUM ASCORBYL PHOSPHATE*†, SODIUM HYALURONATE*†, SODIUM PCA*†, STEARETH-2, STEARETH-21, TAGETES ERECTA (MARIGOLD) FLOWER EXTRACT*†, TETRASODIUM GLUTAMATE DIACETATE*†, THYMUS VULGARIS (THYME) EXTRACT**†, TOCOPHERSOLAN†, TOCOPHERYL ACETATE*†, WATER (AQUA)*†, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT**†,
*NATURAL-DERIVED / DÉRIVÉS DE NATUREL and/or ECOCERT
**CERTIFIED ORGANIC / CERTIFIÉ ORGANIQUE USDA / ECOCERT/BIO-SWISS
†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 SUNSCREEN BROAD SPECTRUM SPF30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63127-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g in 100 g Inactive Ingredients Ingredient Name Strength C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) C14-22 ALCOHOLS (UNII: B1K89384RJ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) SAFFLOWER OIL (UNII: 65UEH262IS) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) HEXYLDECANOL (UNII: 151Z7P1317) ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1) ARGININE (UNII: 94ZLA3W45F) METHYLPROPANEDIOL (UNII: N8F53B3R4R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PANTHENOL (UNII: WV9CM0O67Z) PROPANEDIOL (UNII: 5965N8W85T) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) THYME (UNII: CW657OBU4N) TOCOPHERSOLAN (UNII: O03S90U1F2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) GINGER (UNII: C5529G5JPQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63127-300-01 1 in 1 CARTON 09/20/2017 1 240 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:63127-300-02 1 in 1 CARTON 09/20/2017 2 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(63127-300)