TOTAL AGE DEFY SPF 15 SUNSCREEN- ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream
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Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CREME ANTI-AGE TRES GLOBALE SPF 15/ TOTAL AGE DEFY CREAM SPF 15 SUNSCREEN

Drug Facts

Active ingredients

Ensulizole 1.7%

Octinoxate 7.496%

Octisalate 5%

Octocrylene 1.7%

Oxybenzone 0.45%

Titanium Dioxide 0.5775%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increses your skin cancer and early skin aging. This product has been shown only to help 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 eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions For sunscreen use

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

WATER, DIISOPROPYL SEBACATE, PROPANEDIOL, MYRISTYL MYRISTATE, PARAFFIN, DIMETHICONE, GLYCERYL STEARATE, MINERAL OIL, PEG-100 STEARATE, VEGETABLE OIL, POTASSIUM CETYL PHOSPHATE, SCLEROTIUM GUM, MICROCRYSTALLINE CELLULOSE, PALMITOYL GLYCINE, PALMITIC ACID, STEARIC ACID, TOCOPHERYL ACETATE, SODIUM HYDROXIDE, PHENOXYETHANOL, CAPRYLYL GLYCOL, POLYSILICONE-14, FRAGRANCE, HYDROGENATED VEGETABLE OIL, CELLULOSE GUM, MICA, TITANIUM DIOXIDE, POLYGLYCERYL-10 PENTAOLEATE, TETRASODIUM EDTA, BUTYLENE GLYCOL, ALIMINIUM HYDROXIDE, CASSIA ANGUSTIFOLIA SEED POLYSACCHARIDE, CANDELILA (EUPHORBIA CERIFERA) WAX, CERAMIDE 3, DISODIUM EDTA, D-LIMONENE, BHT, LINALOOL, BENZYL SALICYLATE, TIN OXIDE, HELIANTUS ANNUUS SEED OIL.

Package Labeling:

Pot Bottom Outer

TOTAL AGE DEFY SPF 15 SUNSCREEN
ensulizole, octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:31720-509
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	17 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.96 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	17 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	57.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
PROPANEDIOL (UNII: 5965N8W85T)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
PARAFFIN (UNII: I9O0E3H2ZE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PALMITOYL GLYCINE (UNII: M6V3RIU5KI)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MICA (UNII: V8A1AW0880)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CANDELILLA WAX (UNII: WL0328HX19)
CERAMIDE 3 (UNII: 4370DF050B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
STANNIC OXIDE (UNII: KM7N50LOS6)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:31720-509-10	1 in 1 BOX	12/17/2015	09/30/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/17/2015	09/30/2018

Labeler - S+ (572406531)

Revised: 2/2018

Document Id: 6558c1f2-3efb-9f30-e053-2a91aa0a78a0

Set id: be358e40-1c2b-4b9a-9ac7-f612ffd0b563

Version: 3

Effective Time: 20180216

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