Label: DOLLAR GENERAL STUDIO SELECTION SUN TANNING DRY OIL BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone, homosalate, octisalate, oxybenzone spray
- NDC Code(s): 55910-032-37
- Packager: Dolgencorp, LLC
- 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 July 13, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
Directions
•spray liberally and spread evenly by hand15 minutes before sun exposure
• hold can 4-6 inches away from the skin to apply
• do not spray into face. Spray into hands, then apply to face.• do not apply in windy conditions
• use in well-ventilated areas
reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours• children under 6 months: 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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DOLLAR GENERAL STUDIO SELECTION SUN TANNING DRY OIL BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone, homosalate, octisalate, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) COCONUT OIL (UNII: Q9L0O73W7L) MINERAL OIL (UNII: T5L8T28FGP) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-032-37 156 g in 1 CAN; Type 0: Not a Combination Product 10/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/12/2018 Labeler - Dolgencorp, LLC (068331990)