OTC Medication Information: Safe Sea SPF 50

SAFE SEA SPF 50- octocrylene, homosalate, octisalate and avobenzone lotion
SASA Cosmetics

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 Ingredients:

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Purpose: Sunscreen

Inactive Ingredients: Aqua, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid

Uses: ■ Helps prevent sunburn ■ If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer
and early skin aging caused by the sun.

Warning: ■ 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 rash occurs

Directions: ■ 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 ■ Sun Protection Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: ■ Limit time in the sun, especially from 10 a.m.to 2 p.m.■ Wear long-sleeve shirts, pants, hats, and sunglasses ■ Children under 6 months: Ask a doctor.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Other Information: ■ Give particular attention to coverage of arms and legs. ■ In water infested by Sea Lice, Safe Sea should also be applied
under the bathing suit.■ Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water,
nor is it a guarantee against stings.■ In case of sting do not use Safe Sea as a treatment — seek medical attention.*Tested against Sea nettle
(Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. ■ Protect this product from excessive heat and direct sun.

Principal Display Panel

Front Label

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Back Label

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SAFE SEA SPF 50
homosalate, octocrylene, octisalate, avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66134-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 100 mg in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIBUTYL ADIPATE
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE
STEARYL DIMETHICONE (400 MPA.S AT 50C)
CETYL DIMETHICONE 25
PROPYLENE GLYCOL
HYDROGENATED CASTOR OIL
BENZYL ALCOHOL
LANTHANUM CHLORIDE
MAGNESIUM CHLORIDE
CALCIUM CHLORIDE
CHLORPHENESIN
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
DEHYDROACETIC ACID
BENZOIC ACID
SORBIC ACID
PHAEODACTYLUM TRICORNUTUM
SACCHAROMYCES CEREVISIAE
POLYSULFATED GLYCOSAMINOGLYCAN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66134-003-01 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/06/2019
Labeler — SASA Cosmetics (600481230)
Registrant — SASA Cosmetics (600481230)
Establishment
Name Address ID/FEI Operations
SASA Cosmetics 600481230 manufacture (66134-003)

Revised: 12/2019 SASA Cosmetics

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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