Label: ADVANCED PROTECTION SUNSCREEN SPF-30- octinoxate, octisalate, zinc oxide lotion
- NDC Code(s): 70712-103-11, 70712-103-12
- Packager: BOTANICAL SCIENCE, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 4, 2025
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DIRECTIONS
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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 10AM - 2PM, WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENTS
AQUA, C12-15 ALKYL BENZOATE, HYDROGENATED VEGETABLE OIL, CETYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, CYCLOPENTASILOXANE, CETEARETH-20, CETEARYL ALCOHOL, CETYL DIMETHICONE, SODIUM HYALURONATE, SODIUM PCA, GLYCERIN, CAMELLIA OLEIFERA (JAPANESE GREEN TEA) LEAF EXTRACT, ASCORBIC ACID, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PANAX GINSENG ROOT EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GINKGO BILOBA LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, CITRIC ACID, CYCLOTETRASILOXANE, TRIETHOXYCAPRYLYLSILANE, XANTHAN GUM, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, TETRASODIUM EDTA, DIAZOLIDINYL UREA
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED PROTECTION SUNSCREEN SPF-30
octinoxate, octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70712-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 7 g in 100 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SODIUM HYALURONATE (UNII: YSE9PPT4TH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PCA (UNII: 469OTG57A2) PHENOXYETHANOL (UNII: HIE492ZZ3T) TETRASODIUM EDTA (UNII: MP1J8420LU) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) HYDROGENATED PALM OIL (UNII: 257THB963H) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) PEG-100 STEARATE (UNII: YD01N1999R) XANTHAN GUM (UNII: TTV12P4NEE) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CYCLOPENTASILOXANE (UNII: 0THT5PCI0R) CETEARETH-20 (UNII: YRC528SWUY) CYCLOMETHICONE 4 (UNII: CZ227117JE) ASCORBIC ACID (UNII: PQ6CK8PD0R) CETEARYL ALCOHOL (UNII: 2DMT128M1S) GINKGO BILOBA LEAF (UNII: 19FUJ2C58T) ASIAN GINSENG (UNII: CUQ3A77YXI) GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H) CITRIC ACID (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70712-103-11 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2025 2 NDC:70712-103-12 472 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/04/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/04/2025 Labeler - BOTANICAL SCIENCE, INC. (783654275)
