ALBA BOTANICA HW SUNSCREEN ALOE VERA SPF30- avobenzone, homosalate, octocrylene, octyl salicylate 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.

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Alba Botanica HW Sunscreen Aloe Vera SPF30

Active Ingredient

Avobenzone - 3.0%

Homosalate - 7.5%

Octocrylene - 7.5%

Octyl Salicylate - 5.0%

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 (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

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.

AL01946 Label

ALBA BOTANICA HW SUNSCREEN ALOE VERA SPF30 
avobenzone, homosalate, octocrylene, octyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2008
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
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-2008-128 g in 1 TUBE; Type 0: Not a Combination Product09/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/06/2017
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (081512382)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-2008)

Revised: 4/2021
Document Id: bfc8ea6a-7661-31cc-e053-2a95a90a97a9
Set id: 6535fca9-5cd8-2971-e053-2991aa0a66b5
Version: 6
Effective Time: 20210412
 
The Hain Celestial Group, Inc.