Label: DOLLAR GENERAL STUDIO SELECTION SUN SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 55910-036-11
- 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
- DO NOT USE
- WHEN USING
- STOP USE
- 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: 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
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Inactive ingredients
Water, Butylene Glycol, Microcrystalline Cellulose, Glyceryl Stearate, Behenyl Alcohol, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Retinyl Palmitate (Vitamin A palmitate), Sodium Ascorbyl Phosphate, Stearic Acid, Palmitic Acid, Lauryl Alcohol, Myristyl Alcohol, Cetyl Alcohol, Lecithin, Caprylic/Capric Triglyceride, Chlorphensin, Cellulose Gum, Butylated PVP, Disodium EDTA
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOLLAR GENERAL STUDIO SELECTION SUN SUNSCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) DOCOSANOL (UNII: 9G1OE216XY) BENZYL ALCOHOL (UNII: LKG8494WBH) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) LAURYL ALCOHOL (UNII: 178A96NLP2) MYRISTYL ALCOHOL (UNII: V42034O9PU) CETYL ALCOHOL (UNII: 936JST6JCN) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) CHLORPHENESIN (UNII: I670DAL4SZ) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-036-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/26/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/26/2015 Labeler - Dolgencorp, LLC (068331990)