CELLULAR DAY DEFENSE FIRMING SPF 25- zinc oxide, oxybenzone, and octinoxate cream

Cellular Day Defense Firming SPF 25 by

Drug Labeling and Warnings

Cellular Day Defense Firming SPF 25 by is a Otc medication manufactured, distributed, or labeled by Aloette Cosmetics Inc., Du-Var Laboratory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient
Octinoxate 7.5%	Sunscreen
Oxybenzone 3.0%	Sunscreen
Zinc Oxide 5.0%	Sunscreen

Uses

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Warning

For external use only.

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

If rash or irritation develops and lasts.

Keep out of reach of children: if swallowed, get medical help or contact a poison control center right away.

TO USE

Apply evenly to dry skin, 30 minutes before sun exposure. Children under 6 months of age consult a doctor.

INACTIVE INGREDIENTS

ALOE BARBADENSIS LEAF EXTRACT, AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, CETYL ALCOHOL, ETHYLHEXYL PALMITATE, GLYCERIN, CETEARETH-20, BUTYROSPERMUM PARKII (SHEA BUTTER), MALTODEXTRIN, RICE CONCENTRATE, THEOBROMA CACAO (COCOA) SEED BUTTER, OLEA EUROPAEA (OLIVE) FRUIT OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, PLANKTON EXTRACT, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEAM EXTRACT, MEL EXTRACT, VITIS VINIFERA (GRAPE) SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PUNICA GRANATUM EXTRACT, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, TOCOPHERYL ACETATE, L-GLUTATHIONE, SODIUM CHLORIDE, XANTHAN GUM, GLYCERYL ISOSTEARATE, POLYHYDROXYSTEARIC ACID, PHENOXYETHANOL, CAPRYLYL GLYCOL, FRAGRANCE (PARFUM)

SPL UNCLASSIFIED SECTION

Dist. by Aloette Cosmetics Inc. Atlanta GA 30327

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

ALOETTE

Cellular Day Defense
Firming Complex with SPF 25

NET WT. 1.7 OZ/50 G

INGREDIENTS AND APPEARANCE

CELLULAR DAY DEFENSE FIRMING SPF 25 
zinc oxide, oxybenzone, and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65447-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TRICAPRYLIN (UNII: 6P92858988)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65447-050-02	1 in 1 CARTON
1	NDC: 65447-050-01	50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/15/2011

Labeler - Aloette Cosmetics Inc. (831761320)

Establishment
Name	Address	ID/FEI	Business Operations
Du-Var Laboratory		246768782	MANUFACTURE(65447-050) , PACK(65447-050) , LABEL(65447-050)