Label: OARS AND ALPS SPF 50 MINERAL- zinc oxide lotion
- NDC Code(s): 83046-371-28
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure.
Reapply:
-At least every two hours
-After 80 minutes of swimming or sweating.
-Immediately after towel drying.
Children under six months: 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. -
INACTIVE INGREDIENT
Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Cladonia Stellaris Extract, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sclerocarya Birrea Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OARS AND ALPS SPF 50 MINERAL
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83046-371 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.6 g in 100 mL Inactive Ingredients Ingredient Name Strength METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SODIUM GLUCONATE (UNII: R6Q3791S76) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) COCOA BUTTER (UNII: 512OYT1CRR) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEVOMENOL (UNII: 24WE03BX2T) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) DOCOSANOL (UNII: 9G1OE216XY) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) COCONUT OIL (UNII: Q9L0O73W7L) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) TOCOPHEROL (UNII: R0ZB2556P8) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) COCO GLUCOSIDE (UNII: ICS790225B) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) CLADONIA RANGIFERINA WHOLE (UNII: O21ZF987XQ) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83046-371-28 177 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/01/2022 Labeler - Oars and Alps LLC (040241941)
