Label: OARS AND ALPS SPF 70 HYDRATING ANTIOXIDANT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 83046-370-13
- Packager: Oars and Alps LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 31, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
WARNINGS
- For external use only.
- Flammable. Contents under pressure. Keep away from fire, smoke, other sources of ignition or while smoking. Do not puncture of incinerate can. Do not store above 120 F.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Apply generously and evenly 15 minutes before sun exposure
- Hold container 4-6 inches from the skin to apply
- Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
- Do not apply in windy conditions.
- Use in well ventilated area.
- Reapply: After 80 minutes of swimming or sweating, immedately after towl 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 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.
- Children under six months: Ask a doctor.
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OARS AND ALPS SPF 70 HYDRATING ANTIOXIDANT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83046-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ALCOHOL (UNII: 3K9958V90M) ETHYL FERULATE (UNII: 5B8915UELW) GRAPEFRUIT OIL (UNII: YR377U58W9) CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83046-370-13 177 mL in 1 CAN; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/01/2023 Labeler - Oars and Alps LLC (040241941)
