Label: FACE VALUES ULTRA SPORT ACTIVE SPF 15 SUNSCREEN- avobenzone, homosalate, octisalate aerosol, spray
- NDC Code(s): 63940-070-48
- Packager: HARMON STORES, 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 July 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- Spray liberally and spread evenly by hand 15 minutes before sun exposure
- Hold can 4-6 inches away from the skin to apply
- Do not spray directly into face. Spray into hands then apply to face
- Do not apply in windy conditions
- Use in a well-ventilated area
- 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FACE VALUES ULTRA SPORT ACTIVE SPF 15 SUNSCREEN
avobenzone, homosalate, octisalate aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-070 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 Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) ALOE VERA LEAF (UNII: ZY81Z83H0X) MINERAL OIL (UNII: T5L8T28FGP) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63940-070-48 258 g in 1 CAN; Type 0: Not a Combination Product 02/27/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/27/2008 Labeler - HARMON STORES, INC. (804085293)