NDC | 62217-012-35 |
Set ID | 4fa69e1b-fd2e-302e-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Fruit of the Earth, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- FLAMMABLE:
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
Directions
• apply liberally 15 minutes before sun exposure
• hold can 4-6 inches away from body, spray evenly to ensure
complete coverage
• do not spray into face. Spray into hand and apply to face.
• use in well ventilated, but not windy areas
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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
• children under 6 months: ask a doctor - Other information
- Inactive ingredients
- Questions or comment?
- Fruit of the Earth, Inc. Sport SPF 50 Sunscreen Continuous Spray
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH SPORT SPF 50 SUNSCREEN CONTINUOUS
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 40 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-012-35 148 mL in 1 CAN; Type 0: Not a Combination Product 05/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/16/2017 Labeler - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-012)