Label: AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50- avobenzone, octocrylene, octyl salicylate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-3438-1 - 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 April 12, 2021
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- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water (Aqua), Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Aloe Barbadensis Leaf Juice(1), Calendula Officinalis Flower Extract(1), Camellia Sinensis Leaf Extract(1), Chamomilla Recutita (Matricaria) Flower Extract(1), Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract(1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol(1), Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate.
(1) Certified Organic Ingredient
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INDICATIONS & USAGE
Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.
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INGREDIENTS AND APPEARANCE
AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50
avobenzone, octocrylene, octyl salicylate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-3438 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) XANTHAN GUM (UNII: TTV12P4NEE) GINKGO (UNII: 19FUJ2C58T) CETYL ALCOHOL (UNII: 936JST6JCN) CAPRYLIC/CAPRIC ACID (UNII: DI775RT244) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL OLIVATE (UNII: 58B69Q84JO) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POLYSORBATE 60 (UNII: CAL22UVI4M) BENZYL ALCOHOL (UNII: LKG8494WBH) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) SORBITAN OLIVATE (UNII: MDL271E3GR) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-3438-1 85 g in 1 TUBE; Type 0: Not a Combination Product 12/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/13/2017 Labeler - The Hain Celestial Group, Inc. (117115556) Registrant - The Hain Celestial Group, Inc. (081512382) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 081512382 manufacture(61995-3438)
