Label: SPF 30 MOISTURIZER WITH ALOE VERA- homosalate,octocrylene,avobenzone cream
- NDC Code(s): 83695-001-01
- Packager: Audrey Morris Cosmetics International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 28, 2023
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- Official Label (Printer Friendly)
- Active Ingredients Purpose
- PURPOSE
- Uses
-
Warnings
For Extranal use only
Do not use ondamaged or broken skin.
When using this product- Keep out of eyes. Rinse with water to remove
Stop use and ask doctor
- Rash or irritation develops and lasts
Keep out of reach if children
- If product gets swallowed, get medical help or contact a Poison Control Center right away
- KEEP OUT OF REACH OF CHILDREN
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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 broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10:00a.m – 2:00p.m
- Wear long sleave shirts, pants, hats, and sunglasses.
- Children under 6 Months: Ask a doctor
- Other information
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Inactive Ingredients
Water (Aqua), Adipic Acid, Adipic Acid/Diglycol Crosspolymer, Isopropyl Myristate, Polyester-8, Propylene Glycol, Hydrogenated Polyisobutene, Cetyl alcohol, Sorbitan Stearate, Fragrance, Aloe Barbadensis Leaf Extract, Allantoin, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Retinyl Palmitate, Triethanolamine, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate 20, Carbomer, Phenoxyethanol, Disodium EDTA, Caprylyl Glycol.
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- Product label
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INGREDIENTS AND APPEARANCE
SPF 30 MOISTURIZER WITH ALOE VERA
homosalate,octocrylene,avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83695-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ADIPIC ACID (UNII: 76A0JE0FKJ) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) CETYL ALCOHOL (UNII: 936JST6JCN) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TROLAMINE (UNII: 9O3K93S3TK) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) POLYSORBATE 20 (UNII: 7T1F30V5YH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83695-001-01 170 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/02/2023 Labeler - Audrey Morris Cosmetics International, LLC (101726178)
