SAFE SEA - octinoxate, zinc oxide 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.

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Drug Facts

Inactive Ingredients:  Aqua, Cyclopentasiloxane, Mineral Oil, Lauryl

PEG/PEG - 18/18 Methicone, Cetyl

Dimethicone, Stearyl Dimethicone, Ceresin,

Hydrogenated Castor Oil, Propylene Glycol,

Lanthanum Chloride, Magnesium Chloride,

Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,

Benzyl Alcohol, Fragrance, Chlorphenesin, Benzoic Acid, Sorbic Acid,

Dehydroacetic Acid, Tetrasodium EDTA, Sodium Citrate, Triethoxycaprylylsilane

Active Ingredients:

Octinoxate 7.5 %

Zinc Oxide 2 %

Purpose:

Sunscreen

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 sue and ask a doctor if rash occurs--Keep out of reach

of children -- If product is swallowed, get medical help or contact a Poison

Control Center right away.

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 )

and Rhopilema. Data on file.  - Protect this product from excessive heat and direct sunlight.

copy of label

SAFE SEA 
octinoxate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66134-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
CERESIN (UNII: Q1LS2UJO3A)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LANTHANUM CHLORIDE (UNII: 04M8624OXV)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66134-015-15118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/07/2015
Labeler - SASA Cosmetics (600481230)
Establishment
NameAddressID/FEIBusiness Operations
SASA Cosmetics600481230manufacture(66134-015) , api manufacture(66134-015)

Revised: 1/2015
Document Id: 6dc377d1-8a9d-4d4e-b958-e8485efd9181
Set id: fbf07c1d-de8a-411e-9a39-c7611ab5af4b
Version: 3
Effective Time: 20150106
 
SASA Cosmetics