Label: SUN SHIELD SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 66391-3001-1
- Packager: Winning Solutions
- 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 January 26, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- apply generously 15 minutes before sun exposure.
Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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. and wear long-sleeved shirts, pants, hats and sunglasses. For use on skin only.
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Inactive ingredients
water, glycerin, stearic acid, cetyl alcohol, aloe barbadensis leaf, c12-15 alkyl benzoate, dea-cetyl phosphate, vp/eicosene copolymer, phenoxyethanol, dimethicone, triethanolamine, carbomer, titanium dioxide, glycereth-2 cocoate, tocopheryl acetate, retinyl palmitate, iodopropynyl butylcarbamate, chamomilla recutitita (matricaria) flower extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN SHIELD SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66391-3001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 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 STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERETH-2 COCOATE (UNII: JWM00VS7HC) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) DIMETHICONE (UNII: 92RU3N3Y1O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66391-3001-1 30 mL in 1 TUBE; Type 0: Not a Combination Product 01/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/26/2023 Labeler - Winning Solutions (962718300)
