Label: ALBA BOTANICA HW SUNSCREEN ALOE VERA SPF30- avobenzone, homosalate, octocrylene, octyl salicylate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-2008-1 - 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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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water (Aqua)
Cetyl Alcohol
Glycerin
Caprylic/Capric Triglyceride
Glyceryl Stearate SE
Dimethicone
VP/Hexadecene Copolymer
Citrus Aurantium Dulcis (Orange) Peel Oil
Aloe Barbadensis Leaf Juice (1)
Ananas Sativus (Pineapple) Fruit Extract (1)
Camellia Sinensis Leaf Extract (1)
Carica Papaya (Papaya) Fruit Extract (1)
Hibiscus Sabdariffa Flower Extract (1)
Mangifera Indica (Mango) Fruit Extract (1)
Passiflora Incarnata Flower Extract (1)
Psidium Guajava Fruit Extract
Tocopheryl Acetate
Alcohol
Cetearyl Alcohol
Cetearyl Olivate
Citric Acid
Linalyl Acetate
Polysorbate 60
Sodium Chloride
Sodium Stearoyl Glutamate
Sorbitan Olivate
Triethyl Citrate
Xanthan Gum
Benzyl Alcohol
Potassium Sorbate
Sodium Benzoate
Amyl Cinnamal
Citral
Citronellol
Geraniol
Hydroxycitronellal
Limonene
Linalool
(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
ALBA BOTANICA HW SUNSCREEN ALOE VERA SPF30
avobenzone, homosalate, octocrylene, octyl salicylate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) LINALYL ACETATE (UNII: 5K47SSQ51G) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM BENZOATE (UNII: OJ245FE5EU) MANGO (UNII: I629I3NR86) PINEAPPLE (UNII: 2A88ZO081O) PAPAYA (UNII: KU94FIY6JB) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) GUAVA (UNII: 74O70D6VG0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) GREEN TEA LEAF (UNII: W2ZU1RY8B0) XANTHAN GUM (UNII: TTV12P4NEE) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2008-1 28 g in 1 TUBE; Type 0: Not a Combination Product 09/06/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/06/2017 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(61995-2008)
