TENDER MOMENTS SPF 45

TENDER MOMENTS SPF 45- homosalate octinoxate octisalate oxybenzone titanium dioxide octocrylene lotion
JAFRA COSMETICS INTERNATIONAL

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.

----------

SUNSCREEN ACTIVE INGREDIENT (SPF 45): TITANIUM DIOXIDE, OXYBENZONE/BENZOPHENONE-3, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, ALUMINA, DIMETHICONE, SODIUM DIHYDROXYCETYL PHOSPHATE, GLYCERYL STEARATE SE, ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER, PVP/EICOSENE COPOLYMER, AVENA SATIVA (OAT) KERNEL EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CETYL ALCOHOL, XANTHAN GUM, FRAGRANCE/PARFUM, DMDM HYDANTOIN, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, [FRAGRANCE/PARFUM CONTAINS: CITRONELLOL, GERANIOL, HEXYL CINNAMAL, HYDROXYCITRONELLOL, BUTYLPHENYL METHYLPROPIONAL (LILLIAL), LINALOL, ALPHA-ISOMMETHYL IONONE]

BABY BLOCK SPF 45

APPLY WATER-RESISTANT SUNSCREEN 20 MINUTES BEFORE SUN EXPOSURE.

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

KEEP OUT OF REACH OF CHILDREN.

TENDER MOMENTS
BABY BLOCK SPF 45

JAFRA

WARNINGS: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

SEEK THE ADVICE OF A PHYSICIAN PRIOR TO USE ON CHILDREN UNDER 6 MONTHS OF AGE.

TENDER MOMENTS SPF 45
homosalate octinoxate octisalate oxybenzone titanium dioxide octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-060
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.7 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLENE GLYCOL ADIPATE (UNII: 6KE5V549E0)
OAT (UNII: Z6J799EAJK)
POVIDONE K30 (UNII: U725QWY32X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE TRISODIUM (UNII: 420IP921MB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-060-13	50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/24/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture