Label: FAMILY DOLLAR TROPIC SUN SPF 50 BABY SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 55319-034-14
- Packager: Family Dollar Services 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 February 6, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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 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
- Label
-
INGREDIENTS AND APPEARANCE
FAMILY DOLLAR TROPIC SUN SPF 50 BABY SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 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 Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CHLORPHENESIN (UNII: I670DAL4SZ) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) OLETH-3 (UNII: BQZ26235UC) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) TROLAMINE (UNII: 9O3K93S3TK) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-034-14 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/27/2019 Labeler - Family Dollar Services Inc. (024472631)