Label: SAFE SEA SPF 50 KIDS- homosalate, octocrylene, octisalate, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66134-001-01 - Packager: SASA Cosmetics
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 5, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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
- INDICATIONS & USAGE
- WARNINGS
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INSTRUCTIONS FOR USE
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
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OTHER SAFETY INFORMATION
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
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INGREDIENTS AND APPEARANCE
SAFE SEA SPF 50 KIDS
homosalate, octocrylene, octisalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66134-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIBUTYL ADIPATE (UNII: F4K100DXP3) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) BENZYL ALCOHOL (UNII: LKG8494WBH) LANTHANUM CHLORIDE (UNII: 04M8624OXV) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) CHLORPHENESIN (UNII: I670DAL4SZ) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DEHYDROACETIC ACID (UNII: 2KAG279R6R) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBIC ACID (UNII: X045WJ989B) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66134-001-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/06/2019 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 Business Operations SASA Cosmetics 600481230 manufacture(66134-001)
