SAFE SEA- octinoxate, zinc oxide lotion

Safe Sea by

Drug Labeling and Warnings

Safe Sea by is a Otc medication manufactured, distributed, or labeled by SASA Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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 INGREDIENT

Active Ingredients:

Octinoxate 7.5 %

Zinc Oxide 2 %

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

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

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

Keep out of reach of children. If product is swallowed, get medical help or

contact a Poison Control Center right away.

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 )

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFE SEA 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66134-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66134-015-15	118 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/07/2015

Labeler - SASA Cosmetics (600481230)

Establishment
Name	Address	ID/FEI	Business Operations
SASA Cosmetics		600481230	manufacture(66134-015) , api manufacture(66134-015)