OTC Medication Information: AL0043800 Alba Botanica Sheer Shield Sunscreen FF SPF50

AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50- octisalate, octocrylene, avobenzone and homosalate 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

Avobenzone — 3.0

Octocrylene -10.0

Octyl Salicylate — 5.0

Homosalate — 10.0

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. Children under 6 months: ask a doctor.

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, Glyceryl Stearate SE, Dimethicone, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, 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, Lavandula Angustifolia (Lavender) Flower Extract(1), Panax Ginseng Root Extract, Tocopheryl Acetate, Alcohol(1), Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate.

(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.

AL00438 Label
(click image for full-size original)

AL0043800 ALBA BOTANICA SHEER SHIELD SUNSCREEN FF SPF50
avobenzone, octocrylene, octyl salicylate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-3438
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g in 100 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 3 g in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE 10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
GLYCERIN
WATER
.ALPHA.-TOCOPHEROL ACETATE
GLYCERYL STEARATE SE
GREEN TEA LEAF
CHAMOMILE
XANTHAN GUM
GINKGO
CETYL ALCOHOL
CAPRYLIC/CAPRIC ACID
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
CALENDULA OFFICINALIS FLOWER
PANAX GINSENG ROOT OIL
CETOSTEARYL ALCOHOL
CETEARYL OLIVATE
ANHYDROUS CITRIC ACID
POLYSORBATE 60
BENZYL ALCOHOL
SODIUM CHLORIDE
SODIUM STEAROYL GLUTAMATE
SORBITAN OLIVATE
POTASSIUM SORBATE
SODIUM BENZOATE
DIMETHICONE
ALOE VERA LEAF
LAVANDULA ANGUSTIFOLIA FLOWER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-3438-1 85 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/13/2017
Labeler — The Hain Celestial Group, Inc. (117115556)
Registrant — The Hain Celestial Group, Inc. (081512382)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 081512382 manufacture (61995-3438)

Revised: 04/2021 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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