SAFE SEA SPF 40- octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane spray 
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.

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Drug Facts

Active Ingredients:

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Purpose: Sunscreen

Inactive Ingredients: Aqua, Dibutyl Adipate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Dicaprylyl Ether, PEG-30 Dipolyhydroxystearate, Lauryl PEG/PPG-18/18 Methicone, Isopropyl Myristate, Stearyl Dimethicone, Cetyl dimethicone, Propylene Glycol, VP/Hexadecene Copolymer, Panthenol, Tocopheryl Acetate, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans, Parfum, Chlorphenisin.

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.

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SAFE SEA SPF 40 
octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66134-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LANTHANUM CHLORIDE (UNII: 04M8624OXV)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66134-002-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/06/2019
Labeler - SASA Cosmetics (600481230)
Registrant - SASA Cosmetics (600481230)
Establishment
NameAddressID/FEIBusiness Operations
SASA Cosmetics600481230manufacture(66134-002)

Revised: 12/2019
Document Id: 31476518-dbfd-469d-bdfc-60f0936abcf6
Set id: 94653387-0b85-466a-88ce-2cd1368d2c96
Version: 1
Effective Time: 20191205
 
SASA Cosmetics