BABY GENTLE SUNSCREEN SPF 50- avobenzone - 3.0% homosalate - 13.0% octisalate - 5.0% octocrylene - 7.0% oxybenzone 4% lotion

Baby Gentle Sunscreen SPF 50 by

Drug Labeling and Warnings

Baby Gentle Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by TopCo, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients                         Purpose

Avobenzone 3.0%..........................Sunscreen
Homosalate 13.0%.........................Sunscreen
Octisalate 5.0%..............................Sunscreen
Octocrylene 7.0%...........................Sunscreen
Oxybenzone 4.0%..........................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn higher SPF gives more
sunburn protection retains SPF after 80 minutes of activity in
the water or sweating provides high protection against sunburn

Warnings

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get
medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours
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 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
children under 6 months: Ask a doctor

OTHER SAFETY INFORMATION

Other information protect the product in this
container from excessive heat and direct sun may stain fabrics

INACTIVE INGREDIENT

Inactive ingredients \

Aluminum Starch
Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone,
Disodium EDTA, Fragrance, Methylparaben, Polyglyceryl-3
Distearate, Propylparaben, Sorbitan Isostearate, Sorbitol, Stearic
Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water

Questions? 1-888-423-0139

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY GENTLE SUNSCREEN SPF 50 
avobenzone - 3.0% homosalate - 13.0% octisalate - 5.0% octocrylene - 7.0% oxybenzone 4% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-870
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	13 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	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Benzyl Alcohol (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
Dimethicone (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)
Propylparaben (UNII: Z8IX2SC1OH)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Sorbitol (UNII: 506T60A25R)
Stearic Acid (UNII: 4ELV7Z65AP)
Tocopherol (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-870-06	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/21/2016

Labeler - TopCo (006935977)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(36800-870) , label(36800-870)