TENDER MOMENTS BABY SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (40 MINUTES)- avobenzone, homosalate, octisalate, octocrylene cream

Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) by

Drug Labeling and Warnings

Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

PURPOSE

Uses

Helps Prevent Sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If product is swallowed, get medical help or contact a poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctorif rash occurs.

WARNINGS

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Directions

apply liberally 15 minutes before sun exposure

reapply:

after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

children under 6 months: Ask a doctor

Sun Protection MeasuresSpending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun
protection measures including:

• limit your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients

Water/Aqua, Glycerin, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ethylhexyl Methoxycrylene, Mica/CI 77019, Silica, Bisabolol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Tocopheryl Acetate, Chlorphenesin, Disodium EDTA

OTHER SAFETY INFORMATION

Other information

protect this product from excessive heat and direct sun

Product label

INGREDIENTS AND APPEARANCE

TENDER MOMENTS BABY SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (40 MINUTES) 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-444
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ARGININE (UNII: 94ZLA3W45F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-444-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2021
2	NDC: 68828-444-02	7.5 mL in 1 TUBE; Type 0: Not a Combination Product	06/10/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/10/2021

Labeler - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Distribuidora Comercial Jafra, S.A. de C.V.		951612777	manufacture(68828-444)