Label: BIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30- titanium dioxide, zinc oxide cream
- NDC Code(s): 71447-050-00, 71447-050-01
- Packager: LABORATOIRES DRUIDE INC
- 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 1, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
▪ Apply liberally and evenly 15 minutes before sun exposure ▪ Reapply ▪ After 80 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 ▪ Use a water-resistant sunscreen if swimming or sweating. - Other Information
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Inactive Ingredients
C10-18 Triglycerides, Sodium Citrate, Panax Ginseng Extract*, Tocopherol, Propanediol, Potassium Sorbate, Sodium Stearoyl Glutamate, Hyaluronate Sodium, Aloe Barbadensis Leaf Juice*, Coco-Caprylate, Alumina, Glycerin, Stearic Acid, Xanthan Gum, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Salicylic Acid, Benzyl Alcohol, Isostearic Acid, Sorbic Acid, Cetyl Alcohol, Caprylic/Capric/ Linoleic Triglyceride, Glyceryl Stearate.
*Certified Organic.
- Questions or Comments?
- BIOMI ACTION DE GALA SFP 30 MINERAL SUNSCREEN 50 mL (NDC 73626-050-00)
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INGREDIENTS AND APPEARANCE
BIOMI ACTION DE GALA MINERAL SUNSCREEN SPF30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71447-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.4 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) SODIUM CITRATE (UNII: 1Q73Q2JULR) PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0) TOCOPHEROL (UNII: R0ZB2556P8) PROPANEDIOL (UNII: 5965N8W85T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCO-CAPRYLATE (UNII: 4828G836N6) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) SALICYLIC ACID (UNII: O414PZ4LPZ) BENZYL ALCOHOL (UNII: LKG8494WBH) ISOSTEARIC ACID (UNII: X33R8U0062) SORBIC ACID (UNII: X045WJ989B) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71447-050-01 1 in 1 BOX 03/01/2020 1 NDC:71447-050-00 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 03/01/2020 Labeler - LABORATOIRES DRUIDE INC (245815014) Registrant - LABORATOIRES DRUIDE INC (245815014) Establishment Name Address ID/FEI Business Operations LABORATOIRES DRUIDE INC 245815014 manufacture(71447-050)
