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

Baby Sunscreen SPF 50 by

Drug Labeling and Warnings

Baby Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Rite Aid, 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

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY SUNSCREEN SPF 50  TUGABOOS
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: 11822-7789
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: 11822-7789-6	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/26/2016

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(11822-7789)