Label: HAWAIIAN SPF 30 ALOE SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion
- NDC Code(s): 61995-2028-1, 61995-2028-2, 61995-2028-3
- 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 22, 2023
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- ACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
● Apply liberally 15 minutes before sun exposure ● Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours ● Children under 6 months of age: ask a doctor
● Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use 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 am - 2 pm
● wear long-sleeved shirts, pants, hats, and sunglasses
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water (Aqua), Butyloctyl Salicylate, Dodecane, VP/Hexadecene Copolymer, Polyglyceryl-10 Pentastearate, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Glyceryl Oleate Citrate, Behenyl Alcohol, Phenoxyethanol, 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 (1), Lavandula Angustifolia (Lavender) Flower/Leaf/ Stem Extract (1), Panax Ginseng Root Extract (1), Tocopheryl Acetate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Decane, Nonane, Potassium Hydroxide, Sodium Phytate, Sodium Stearoyl Lactylate, Solanum Tuberosum (Potato) Starch, Sorbitan Olivate, Alcohol (1), Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate
(1) Certified Organic Ingredient
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAWAIIAN SPF 30 ALOE SUNSCREEN
avobenzone, homosalate, octocrylene, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength GINKGO BILOBA WHOLE (UNII: 660486U6OI) PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0) CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85) ALCOHOL (UNII: 3K9958V90M) CETEARYL OLIVATE (UNII: 58B69Q84JO) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM BENZOATE (UNII: OJ245FE5EU) ALOE VERA WHOLE (UNII: KIZ4X2EHYX) BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL OLEATE (UNII: 4PC054V79P) BEHENYL BEHENATE (UNII: K8NU647RJ0) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) STARCH, POTATO (UNII: 8I089SAH3T) C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-2028-1 59 g in 1 TUBE; Type 0: Not a Combination Product 08/19/2019 2 NDC:61995-2028-2 89 g in 1 TUBE; Type 0: Not a Combination Product 08/19/2019 3 NDC:61995-2028-3 113 g in 1 TUBE; Type 0: Not a Combination Product 08/19/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/19/2019 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(61995-2028)
