TENDER MOMENTS BABY SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA- avobenzone, homosalate, octisalate, octocrylene, oxybenzone liquid

Tender Moments Baby Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Tender Moments Baby Sunscreen Broad Spectrum SPF 50 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

Active ingredients     Purpose

Avobenzone 3%       Sunscreen

Homosalate 10%      Sunscreen

Octisalate 5%           Sunscreen

Octocrylene 7%        Sunscreen

Oxybenzone 5%       Sunscreen     

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 by the sun.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

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

Directions

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

Sun Protection Measures

Spending 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 time in the sun, especially from 10 a.m.-2 p.m.

       wear long-sleeve shirts, pants , hats, and sunglasses.

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Avena Sativa (Oat) Kernel Extract, Behenyl Alcohol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Panthenol, PEG-100 Stearate, Sodium Hydroxide, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.

PRINCIPAL DISPLAY PANEL

Jafra

Tender Moments

Baby Sunscreen Broad Spectrum SPF 50

50 ml 1.7 Fl Oz

INGREDIENTS AND APPEARANCE

TENDER MOMENTS BABY SUNSCREEN BROAD SPECTRUM SPF 50  JAFRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-177
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	7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
OAT (UNII: Z6J799EAJK)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAUROYL LYSINE (UNII: 113171Q70B)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-177-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	09/30/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/30/2013

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(68828-177)