Label: SIGNATURE CARE SHEER FACE AND BODY SPF 70 SUNSCREEN- avobenzone, homosalate,octisalate,octocrylene,oxybenzone stick
- NDC Code(s): 21130-721-36
- Packager: SAFEWAY, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 19, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- INDICATIONS & USAGE
- Warnings
- Stop use and ask a doctor if
- 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
• 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 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
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SIGNATURE CARE SHEER FACE AND BODY SPF 70 SUNSCREEN
avobenzone, homosalate,octisalate,octocrylene,oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-721 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CERESIN (UNII: Q1LS2UJO3A) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PARAFFIN (UNII: I9O0E3H2ZE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) YELLOW WAX (UNII: 2ZA36H0S2V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-721-36 42 g in 1 TUBE; Type 0: Not a Combination Product 11/13/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/13/2017 Labeler - SAFEWAY, INC. (009137209) Registrant - FRUIT OF THE EARTH, INC. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(21130-721)