Label: MINERAL UNSEEN SUNSCREEN SPF 40- titanium dioxide, zinc oxide lotion
- NDC Code(s): 75936-623-01, 75936-623-02, 75936-623-03, 75936-623-04
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 23, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly 15 minutes before sun exposure
Reapply (will vary depending on WR)
after XX minutes of swimming or sweating
Immediately after towel drying
at least every 2 hours
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
Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients: DIMETHICONE, DIMETHICONE CROSSPOLLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYL DIHYDROABIETATE, POLYHYDROXYSTEARIC ACID, C9-12 ALKANE, GLYCERIN, ETHYLHEXYLGLYCERIN, WATER (AQUA), COCO-CAPRYLATE/CAPRATE, SILICA, STEARIC ACID, HEDYCHIUM CORONARIUM ROOT EXTRACT, PROPANEDIOL, SCHIZANDRA CHINENSIS FRUIT EXTRACT, TOCOPHEROL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL UNSEEN SUNSCREEN SPF 40
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-623 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.68 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.33 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) C9-12 ALKANE (UNII: 7J5R5W72QM) HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) STEARIC ACID (UNII: 4ELV7Z65AP) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PROPANEDIOL (UNII: 5965N8W85T) SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-623-02 1 in 1 BOX 10/23/2023 1 NDC:75936-623-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:75936-623-03 15 mL in 1 TUBE; Type 0: Not a Combination Product 10/23/2023 3 NDC:75936-623-04 10 mL in 1 TUBE; Type 0: Not a Combination Product 10/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/23/2023 Labeler - Supergoop, LLC (117061743)