Label: AL00378 ALBA COOL SPORT SUNSCREEN SPF50- avobenzone, homosalate, octocrylene, octyl salicylate spray
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2378-6 - Packager: The Hain Celestial Group, 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 February 5, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only. Flammable.Do not use near heat, sparks or flames or while smoking. Do not puncture orincinerate. Contents under preassure .Do not store at temperature above 120°C. Do not use on damaged or broken skin. When using this product keep out of eye. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure.Hold 4 to 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- ventilated areas. Reapply after 80 min of swimming or sweating, immediately after towel drying and at lease every two hrs. Children under 6 months: ask a doctor.
Skin protection measures:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease a risk,regularly use a Sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially 10am- 2pm, wear long- sleeved shirts,pants, hats and sunglasses.
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INACTIVE INGREDIENT
Alcohol, Acrylates/Octylacrylamide Copolymer, Persea Gratissima (Avocado) Oil, Diisopropyl Adipate, Citrus Limon (lemon) Oil, Aloe Barbadensis Leaf Juice, Amyris Balsamifera Bark Oil, Camellia Sinensis Leaf Extract, Chamomilla Recuitita (Matricaria) Flower Extract, Panax Ginseng Root Extract, Gingko Biloba Root Extract, Tocopheryl Acetate, Triethyl Citrate, Benzyl Salicylate, Citral, Citronellol, Hexyl Cinnamal, Hydroxycitronellol, Limonene.
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AL00378 ALBA COOL SPORT SUNSCREEN SPF50
avobenzone, homosalate, octocrylene, octyl salicylate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2378 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g Inactive Ingredients Ingredient Name Strength CHAMOMILE (UNII: FGL3685T2X) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) ALOE VERA LEAF (UNII: ZY81Z83H0X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GINKGO (UNII: 19FUJ2C58T) ASIAN GINSENG (UNII: CUQ3A77YXI) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALCOHOL (UNII: 3K9958V90M) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) LIMONENE, (+)- (UNII: GFD7C86Q1W) AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E) LEMON OIL (UNII: I9GRO824LL) AVOCADO OIL (UNII: 6VNO72PFC1) PEPPERMINT OIL (UNII: AV092KU4JH) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2378-6 177 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/14/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/14/2016 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(61995-2378)
