Label: DAILY DOSE BIORETINOL MINERAL SPF 40- zinc oxide liquid
- NDC Code(s): 75936-604-01, 75936-604-02, 75936-604-03, 75936-604-04
- Packager: Supergoop, 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 October 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
• apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweatingSun 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 • Children under 6 months: Ask a doctor
-
INACTIVE INGREDIENT
Inactive Ingredients:
Aqua/Water/Eau, Dicaprylyl Ether, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Silica, Olive Oil Polyglyceryl-6 Esters, Isohexadecane, Glycerin, Sorbitan Oleate, VP/Hexadecene Copolymer, Polyhydroxystearic acid, Polyglyceryl-6 Pentaoleate, Propanediol, Bakuchiol, Ethylhexylglycerin, Isododecane, Sodium Chloride, Tocopherol, Disteardimonium Hectorite, Camellia Sinensis Leaf Extract, Propylene Carbonate, Quercus Robur Bark Extract, Quercus Robur Wood Extract, Vitis Vinifera (Grape) Seed Extract, Carnosine, Trisodium Ethylenediamine Disuccinate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAILY DOSE BIORETINOL MINERAL SPF 40
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-604 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16.5 g in 100 mL Inactive Ingredients Ingredient Name Strength QUERCUS ROBUR TWIG BARK (UNII: 2JFK226947) DICAPRYLYL ETHER (UNII: 77JZM5516Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) SODIUM CHLORIDE (UNII: 451W47IQ8X) TOCOPHEROL (UNII: R0ZB2556P8) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) PROPYLENE CARBONATE (UNII: 8D08K3S51E) QUERCUS ROBUR WOOD (UNII: 1B1CMC06QJ) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ISOHEXADECANE (UNII: 918X1OUF1E) GLYCERIN (UNII: PDC6A3C0OX) POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X) PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) VITIS VINIFERA SEED (UNII: C34U15ICXA) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) PROPANEDIOL (UNII: 5965N8W85T) BAKUCHIOL (UNII: OT12HJU3AR) ISODODECANE (UNII: A8289P68Y2) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CARNOSINE (UNII: 8HO6PVN24W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-604-02 1 in 1 BOX 10/18/2022 1 NDC:75936-604-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:75936-604-03 6.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/18/2022 3 NDC:75936-604-04 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 10/18/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/18/2022 Labeler - Supergoop, LLC (117061743)
