SHEER SUNSCREEN SPF 30 MEIJER- avobenzone 3.00% homosalate 8.00% octisalate 5.00% octocrylene 4.00% oxybenzone 4.00% lotion
Meijer

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients Purpose

Avobenzone - 3.00%
Homosalate - 8.00%
Octisalate - 5.00%
Octocrylene - 4.00%
Oxybenzone - 4.00% Sunscreen

- 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

applyliberally and spread evenly by hand 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

Behenyl Alcohol
BHT
Butyloctyl Salicylate
Caprylyl Methicone
Dimethicone
Dimethyl Capramide
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Fragrance
Glyceryl Stearate
Hydrated Silica
PEG-100 Stearate
Phenoxyethanol
Polyester-8
Sodium Polyacrylate
Styrene/Acrylate Copolymer
Trideceth-6
Trimethylsiloxysilicate
VP/Hexadecene Copolymer
Water
Xanthan Gum

image description

SHEER SUNSCREEN SPF 30 MEIJER
avobenzone 3.00% homosalate 8.00% octisalate 5.00% octocrylene 4.00% oxybenzone 4.00% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-783
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	8 g in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	4 g in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethyl Capramide (UNII: O29Y6X2JEZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
Ethylhexylglycerin (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Hydrated Silica (UNII: Y6O7T4G8P9)
PEG-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
Trideceth-6 (UNII: 3T5PCR2H0C)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-783-04	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/09/2017

Labeler - Meijer (006959555)

Registrant - Product Quest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg		927768135	manufacture(41250-783) , label(41250-783)