Label: ABSOLUTELY NATURAL BROAD SPECTRUM SPF 8 SUNSCREEN- zinc oxide lotion
- NDC Code(s): 70793-038-03, 70793-038-10
- 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 17, 2023
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- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only.
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 doctor if rash occurs.
- Directions
- 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 8 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70793-038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 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:70793-038-03 88.72 mL in 1 TUBE; Type 0: Not a Combination Product 05/17/2023 2 NDC:70793-038-10 10 mL in 1 PACKET; Type 0: Not a Combination Product 05/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/17/2023 Labeler - Absolutely Natural (166425202) Establishment Name Address ID/FEI Business Operations Absolutely Natural 166425202 manufacture(70793-038)