7-IN-1 ANTI-AGING VITAMIN MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream
Meijer Distribution Inc

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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7-in-1 Anti-Aging Vitamin Moisturizer Broad Spectrum SPF15 Sunscreen

Drug Facts

Active ingredients

Avobenzone, 3.0%

Homosalate, 4.0%

Octisalate, 4.5%

Octocrylene, 2.6 %

Purpose

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 caused by the sun.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• children under 6 months of age: 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-sleeved shirts, pants, hats and sunglasses.

Other information

• protect the product in this container from excessive hear and direct sun

Inactive ingredients

Water, Glycerin, Isopropyl Isostearate, Niacinamide, PTFE, Cetearyl Alcohol, Cetearyl Glucoside, Stearyl Alcohol, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Dimethiconol, Behenyl Alcohol, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Panthenol (ProVitamin B5), Tocopheryl Acetate (Vitamin E), Stearic Acid, Benzyl Alcohol, Carbomer, Silica, Stearic Acid, Titanium Dioxide, Zinc Oxide, Triethoxycaprylylsilane, Disodium EDTA, PEG-100 Stearate, BHT, Sodium Hydroxide, Camellia Sinensis Leaf Extract.

Package Labeling:

Label

7-IN-1 ANTI-AGING VITAMIN MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41250-883
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DOCOSANOL (UNII: 9G1OE216XY)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARIC ACID (UNII: 4ELV7Z65AP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41250-883-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/18/2019	12/31/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/18/2019	12/31/2022

Labeler - Meijer Distribution Inc (006959555)

Revised: 6/2023

Document Id: fe2d99ed-a9dd-4fa5-e053-6394a90a2a81

Set id: edffdef8-e705-4c3f-a126-94df12231b93

Version: 2

Effective Time: 20230615

Meijer Distribution Inc