LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN- zinc oxide lotion

La Defense Broad Spectrum SPF 30 Mineral Sunscreen by

Drug Labeling and Warnings

La Defense Broad Spectrum SPF 30 Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Luzern Laboratories, Inc, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide (CI 77947) 15%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner.

Keep out of reach of children.

Consult a health care practitioner prior to use on children less than six months of age.

Directions

Apply liberally before sun exposure. Reapply every 2 hours of sun exposure, or after swimming, excessive perspiration, or towel drying.

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

LA DEFENSE

BROAD SPECTRUM SPF 30
MINERAL SUNSCREEN

LARGE SPECTRE SPF 30
PROTECTION SOLAIRE MINÉRALE

LUZERN®
LABORATORIES

ALL SKIN TYPES TOUS TYPES DE PEAU

1.7 FL OZ / 50 ml

INGREDIENTS AND APPEARANCE

LA DEFENSE BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN 
zinc oxide lotion

Product 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)