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

TENDER MOMENTS by

Drug Labeling and Warnings

TENDER MOMENTS by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

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]

INDICATIONS & USAGE

BABY BLOCK SPF 45

DOSAGE & ADMINISTRATION

APPLY WATER-RESISTANT SUNSCREEN 20 MINUTES BEFORE SUN EXPOSURE.

STOP USE

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

TENDER MOMENTS
BABY BLOCK SPF 45

JAFRA

WARNINGS

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

PEDIATRIC USE

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

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