ALBA HW SUNSCREEN SOOTHING ALOE VERA SPF30- homosalate, octisalate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane, titanium dioxide lotion 
The Hain Celestial Group, Inc.

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.

----------

Active Ingredient

Homosalate - 7.5%

Octocrylene - 7.5%

Ethylhexyl Salicylate - 5.0%

Butyl Methoxydibenzoylmethane - 3.0%

Titanium Dioxide - 1.0%

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.

Sunscreen

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Ananas Sativus (Pineapple) Fruit Extract (1), Carica Papaya (Papaya) Fruit Extract (1), Hibiscus Sabdariffa Flower Extract (1), Magnifera Induca (Mango) Fruit Extract (1), Passiflora Incarnata Flower Extract (1), Psidium Guajava Fruit Extract, Cetearyl Alcohol, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

(1) Certified Organicf Ingredient

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.

tube label

ALBA HW SUNSCREEN SOOTHING ALOE VERA SPF30 
homosalate, octisalate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
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)  
HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PINEAPPLE (UNII: 2A88ZO081O)  
PAPAYA (UNII: KU94FIY6JB)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
MANGO (UNII: I629I3NR86)  
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
GUAVA (UNII: 74O70D6VG0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2025-4113 g in 1 TUBE; Type 0: Not a Combination Product02/13/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/13/2014
Labeler - The Hain Celestial Group, Inc. (858894996)
Registrant - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-2025)

Revised: 11/2014
Document Id: 08c86fc6-47a4-288b-e054-00144ff88e88
Set id: 08c86fc6-47a3-288b-e054-00144ff88e88
Version: 1
Effective Time: 20141126
 
The Hain Celestial Group, Inc.