NDC | 63127-100-01 |
Set ID | cd2106be-7439-40d0-b4f0-b3b51134bb98 |
Category | HUMAN OTC DRUG LABEL |
Packager | Luzern Laboratories, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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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†, CETYL ALCOHOL*†, CITRIC ACID*†, CUCUMIS SATIVUS (CUCUMBER) OIL**†, CYCLOMETHICONE†, 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, 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-SUISSE
† ENVIRONMENTAL WORKING GROUP (EWG) 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 BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63127-100 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 mL Inactive Ingredients Ingredient Name Strength BUDDLEJA DAVIDII LEAF (UNII: X380815D32) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) C14-22 ALCOHOLS (UNII: B1K89384RJ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 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) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) HEXYLDECANOL (UNII: 151Z7P1317) ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1) ARGININE (UNII: 94ZLA3W45F) LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I) 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:63127-100-01 1 in 1 CARTON 03/13/2014 1 50 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 03/13/2014 Labeler - Luzern Laboratories, Inc (188040476) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing, Inc. 793406000 MANUFACTURE(63127-100)