Label: AL0040400 ALBA VE MINERAL SUNSCREEN SPF35- zinc oxide, titanium dioxide spray
- NDC Code(s): 61995-2404-6
- Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 5, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Aqua (Water), Caprylic Capric Triglyceride, Glyceryl Oleate Citrate, Glycerin, Coco-Caprylate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Polyhydroxystearic Acid, Tocopheryl Acetate, Sodium Chloride, Stearic Acid, Xanthan Gum, Phenoxyethanol, Potassium Sorbate.
- INDICATIONS & USAGE
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WHEN USING
SHAKE WELL before use. Apply liberally 15 minutes before sun explosure. Hold 4-6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Use in well ventillated areas. Reapply after 80 minutes of swimming or sweating, immideately after towel drying and at least every 2 hours. Cildren under 6 months: ask doctor. Sun Protection Measures: Spending time in the sun increasis your risk of skin cancer and early skin aging. To decrease risk, regulary use a sunscreen with Broad Spectrum SPF 15 or higher and other preventive measures including: limit time in sun, especially from 10 am to 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AL0040400 ALBA VE MINERAL SUNSCREEN SPF35
zinc oxide, titanium dioxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2404 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.4 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.8 g in 100 g Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) COCO-CAPRYLATE (UNII: 4828G836N6) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) GLYCERYL OLEATE (UNII: 4PC054V79P) XANTHAN GUM (UNII: TTV12P4NEE) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GINKGO (UNII: 19FUJ2C58T) SODIUM CHLORIDE (UNII: 451W47IQ8X) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2404-6 177 g in 1 CAN; Type 0: Not a Combination Product 01/13/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/13/2016 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (014334364) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-2404)
