RENEWING ANTIOXIDANT TREATMENT SPF 6 GNLD INTERNATIONAL- avobenzone, octyl methoxycinnamate 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 Temmentec AG, Active Ingredients Purpose Avobenzone 1.7%, Octyl methoxycinnamate 6.0% . . . . . . . . . . . . . . . Sunscreen, Temmentec Ag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 1.7%, Octyl methoxycinnamate 6.0% . . . . . . . . . . . . . . . Sunscreen

Uses for sunburn protection

helps prevent sunburn

higher SPF gives more sunburn protection

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only 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

Directions for Sunscreen use

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 ingredients

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, Ethylhexylglycerin.

PRINCIPAL DISPLAY PANEL

Nutriance

Renewing Antioxidant Treatment

Antioxidant Cream with sunscreen

SPF 6

Net Wt. 1.7 oz/50g

  

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68807-102
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)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
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)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
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)
MYRETH-4 (UNII: BJT811863E)
CETEARETH-15 (UNII: 867H4YOZ8Z)
CETEARETH-25 (UNII: 8FA93U5T67)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-30 STEARATE (UNII: 1U8KB35S20)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68807-102-02	1 in 1 CARTON
1	NDC: 68807-102-01	50 g in 1 JAR; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2014

Labeler - Temmentec AG (480586411)

Registrant - <text xmlns="urn:hl7-org:v3"> <paragraph/> <paragraph>Active Ingredients Purpose</paragraph> <paragraph>Avobenzone 1.7%, Octyl methoxycinnamate 6.0% . . . . . . . . . . . . . . . Sunscreen</paragraph></text> (948995019)

Establishment
Name	Address	ID/FEI	Business Operations
Temmentec Ag		480586411	manufacture(68807-102)