Label: ABSOLUTELY NATURAL BROAD SPECTRUM SPF 15 SUNSCREEN- zinc oxide lotion
- NDC Code(s): 70793-037-03, 70793-037-10
- Packager: Absolutely Natural
- 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 May 20, 2023
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- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
• Apply liberally and evenly 15 minutes prior to sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating
• 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
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Inactive ingredients
Aloe barbadensis leaf juice, caprylic/capric triglyceride, polyhydroxystearic acid, water, ethylhexyl olivate, squalane, isoamyl laurate, lauryl laurate, sorbitan olivate, silica, copernicia cerifera (carnauba) wax, oryza sativa (rice) bran wax, c13-15 alkane, disteardimonium hectorite, polyglyceryl-3 polyricinoleate, hydrogenated rapeseed oil, capryloyl glycerin/sebacic acid copolymer, propanediol, citrullus lanatus (watermelon) seed oil, butyrospermum parkii (shea) butter, rosa canina fruit oil, cocos nucifera (coconut) oil, helianthus annuus (sunflower) seed oil, camellia sinensis leaf extract, oryza sativa (rice) bran extract, rosmarinus officinalis (rosemary) leaf extract, helianthus annuus (sunflower) extract, tocopherol, sodium phytate, phenoxyethanol, ethylhexylglycerin, sodium chloride, fragrance.
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INGREDIENTS AND APPEARANCE
ABSOLUTELY NATURAL BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70793-037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) WATER (UNII: 059QF0KO0R) ETHYLHEXYL OLEATE (UNII: R34927QY59) SQUALANE (UNII: GW89575KF9) ISOAMYL LAURATE (UNII: M1SLX00M3M) LAURYL LAURATE (UNII: GPW77G0937) SORBITAN OLIVATE (UNII: MDL271E3GR) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARNAUBA WAX (UNII: R12CBM0EIZ) RICE BRAN (UNII: R60QEP13IC) C13-15 ALKANE (UNII: 114P5I43UJ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) PROPANEDIOL (UNII: 5965N8W85T) WATERMELON SEED OIL (UNII: L33J06UQTT) SHEA BUTTER (UNII: K49155WL9Y) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ROSEMARY (UNII: IJ67X351P9) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) TOCOPHEROL (UNII: R0ZB2556P8) PHYTATE SODIUM (UNII: 88496G1ERL) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70793-037-03 88.72 mL in 1 TUBE; Type 0: Not a Combination Product 05/20/2023 2 NDC:70793-037-10 10 mL in 1 PACKET; Type 0: Not a Combination Product 05/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/20/2023 Labeler - Absolutely Natural (166425202) Establishment Name Address ID/FEI Business Operations Absolutely Natural 166425202 manufacture(70793-037)