Label: MINERAL TINTED FACE SUNSCREEN SPF 30 - LIGHT/ MEDIUM- zinc oxide and titanium dioxide cream
MINERAL TINTED FACE SUNSCREEN SPF 30 - MEDIUM/ DARK- zinc oxide and titanium dioxide cream
- NDC Code(s): 73455-011-28, 73455-111-30
- Packager: Unsun Cosmetics
- 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 March 24, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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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 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 avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if rash occurs.
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Directions
Adults and children over 6 months of age: Apply liberally and evenly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or perspiring heavily or immediately after towel drying or washing, at least every 2 hours. 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.
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Non-medicinal ingredients
Water/Aqua/Eau, Caprylic/Capric Triglyceride, Isoamyl Laurate, Glycerin, Polyglyceryl-2 Sesquioleate, Coconut Alkanes, Polyglyceryl-3 Ricinoleate, Crambe Abyssinica (Abyssinian) Seed Oil, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Heptyl Undecylenate, Alumina, Stearic Acid, Magnesium Sulfate, Sodium Chloride, Coco-Caprylate/Caprate, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Juice, Beeswax/Cera Alba/Cire d' Abeille, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Ascorbic Acid, Beta Vulgaris (Beet) Root Extract, Citric Acid, Citrus Aurantium Amara (Bitter Orange) Fruit Extract, Citrus Aurantium Sinensis Peel Extract, Citrus Reticulata (Tangerine) Fruit Extract, Glycine Soja (Soybean) Oil, Hydrolyzed Corn Starch, Lactic Acid, p-Anisic Acid, Tocopherol, Triethoxycaprylylsilane, Iron Oxides (CI 77491, CI 77492, CI 77499).
- Other information
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Label - Light Medium
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Label - Medium Dark
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INGREDIENTS AND APPEARANCE
MINERAL TINTED FACE SUNSCREEN SPF 30 - LIGHT/ MEDIUM
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73455-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.065 g in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.055 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) COCONUT ALKANES (UNII: 1E5KJY107T) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) Heptyl Undecylenate (UNII: W77QUB6GXO) Product Characteristics Color BROWN (tan) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73455-011-28 1 in 1 BOX 04/15/2019 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/15/2019 MINERAL TINTED FACE SUNSCREEN SPF 30 - MEDIUM/ DARK
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73455-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.065 g in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.055 g in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) COCONUT ALKANES (UNII: 1E5KJY107T) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K) Sorbitan Sesquioleate (UNII: 0W8RRI5W5A) Heptyl Undecylenate (UNII: W77QUB6GXO) Product Characteristics Color BROWN (beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73455-111-30 1 in 1 BOX 04/15/2019 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/15/2019 Labeler - Unsun Cosmetics (080766704) Establishment Name Address ID/FEI Business Operations Pack On Demand 610511326 MANUFACTURE(73455-011, 73455-111)
