Label: WAX SPF 50- zinc oxide, allantoin ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 82177-002-00 - Packager: Biomin 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 June 2, 2022
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- DRUG FACTS
- Active Ingredients
- Uses:
- Warnings:
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Directions:
- Apply liberally 15 minutes before sun exposure and as needed. Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every two 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 the 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 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses.
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Inactive Ingredients:
Simmondsia Chinensis (Jojoba) Seed Oil, Jojoba Esters, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil (Argan Oil), Tocopherol, Bisabolol, Calcium Silicate, Phytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Oryza Sativa (Rice) Bran Oil, Oryza Sativa (Rice) Bran Wax, Rhus Succedanea Fruit Wax, Helianthus Annuus (Sunflower) Seed Oil
- Other Information:
- Package Labeling:
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INGREDIENTS AND APPEARANCE
WAX SPF 50
zinc oxide, allantoin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82177-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 200 mg in 1 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ARGAN OIL (UNII: 4V59G5UW9X) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) CALCIUM SILICATE (UNII: S4255P4G5M) RICE BRAN OIL (UNII: LZO6K1506A) RICE BRAN (UNII: R60QEP13IC) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82177-002-00 60 mL in 1 JAR; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/01/2022 Labeler - Biomin LLC. (105075828)