SAFE SEA SPF 50 - octinoxate, octisalate, avobenzone, titanium dioxide 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.

----------

Drug Facts

Inactive Ingredients:  Aqua, Cyclopentasiloxane, Stearyl Dimethicone, Cetyl Dimethicone,

Propylene Glycol, Lauryl PEG / PPG - 18/18 Methicone, Cetyl PEG/PPG-10/1 Dimethicone,

Hydrogenated Castor Oil,  Panthenol, Tocopheryl Acetate, 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, Trimethoxycaprylylsilane

Active Ingredients:

Octinoxate 7.5 %

Octisalate 5 %

Zinc Oxide 5 %

Titanium Dioxide 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 form excessive heat

and direct sunlight

copy of label

SAFE SEA SPF 50 
octinoxate, octisalate, avobenzone, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66134-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LANTHANUM CHLORIDE (UNII: 04M8624OXV)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
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)  
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66134-050-50118 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(66134-050) , api manufacture(66134-050)

Revised: 1/2015
Document Id: 46af1cb0-86e5-4a67-b80d-fb1b0c39440c
Set id: ac7ee36b-a361-4240-b7a3-1b36e298cf7a
Version: 2
Effective Time: 20150107
 
SASA Cosmetics