RENEWING ANTIOXIDANT TREATMENT SPF 6 GNLD INTERNATIONAL- octyl methoxycinnamate, avobenzone cream

Renewing Antioxidant Treatment SPF 6 by

Drug Labeling and Warnings

Renewing Antioxidant Treatment SPF 6 by is a Otc medication manufactured, distributed, or labeled by GNLD International, Temmentec Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Octyl Methoxycinnamate 6.0 % Sunscreen

Avobenzone 1.7 % Sunscreen

PURPOSE

Uses

helps prevent sunburn

higher SPF gives more sunburn protection

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash or irritation develops and lasts.

WARNINGS

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This prduct has been shown only to prevent sunburn, not skin cancer or early skin aging.

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

after moisturizing, apply evenly to entire face and neck

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Water, PPG-2 Myristyl Ether Propionate, Butylene Glycol, Glyceryl Stearate, Tocopheryl Acetate, Decyl Oleate, Hydrogenated Coco-Glycerides, Isostearyl Isostearate, Cetearyl Alcohol, Dimethicone, Stearyl Alcohol, Shea Butter Extract, Olive Oil, Cyclomethicone, Hydrolysed Milk Protein, Niacinamide, Adenosine Triphosphate, Retinyl Palmitate, Peanut Oil, Lecithin, Ascorbyl Palmitate, Tocopherol, Green Tea Extract, Coneflower Extract, Xanthan Gum,Propylene Glycol, Disodium EDTA, Myristyl Alcohol, Myreth-4, Ceteareth-15, Ceteareth-20, Ceteareth-25, Cetyl Alcohol, PEG-30 Stearate, Fragrance, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben and Propylparaben.

PRINCIPAL DISPLAY PANEL

Renewing Antioxidant Treatment

Antioxidant Cream with sunscreen SPF 6

Net. Wt. 1.7 oz./ 50 g

INGREDIENTS AND APPEARANCE

RENEWING ANTIOXIDANT TREATMENT SPF 6  GNLD INTERNATIONAL
octyl methoxycinnamate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76169-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DECYL OLEATE (UNII: ZGR06DO97T)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SHEANUT OIL (UNII: O88E196QRF)
OLIVE OIL (UNII: 6UYK2W1W1E)
CYCLOMETHICONE (UNII: NMQ347994Z)
NIACINAMIDE (UNII: 25X51I8RD4)
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PEANUT OIL (UNII: 5TL50QU0W4)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CETEARETH-15 (UNII: 867H4YOZ8Z)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETEARETH-25 (UNII: 8FA93U5T67)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-30 STEARATE (UNII: 1U8KB35S20)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76169-101-02	1 in 1 BOX
1	NDC: 76169-101-01	50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/22/2011

Labeler - GNLD International (948995019)

Registrant - GNLD International (948995019)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture(76169-101)