NDC | 66134-040-40 |
Set ID | e5f6e3dc-d03e-451d-9a6e-a26985b8491c |
Category | HUMAN OTC DRUG LABEL |
Packager | SASA Cosmetics |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
-
INACTIVE INGREDIENT
Inactive Ingredients: Aqua, Cyclopentasiloxane, Stearyl Dimethicone,
Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propylene
Glycol, Cetyl dimethicone, Lanthanum Chloride, Magnesium Chloride,
Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,
Benzyl Alcohol, Fragrance, Chlorphenesin, Benzoic Acid, Sorbic Acid,
Dehydroacetic Acid, Tetrasodum EDTA, Sodium Citrate, Trimethoxycaprylylsilane
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
-
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 form excessive heat
and direct sunlight
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SAFE SEA SPF 40
octinoxate, octisalate, octocrylene. avobenzone, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66134-040 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 35 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 15 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) 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) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66134-040-40 118 g in 1 TUBE; Type 0: Not a Combination Product 01/07/2015 04/30/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/07/2015 04/30/2022 Labeler - SASA Cosmetics (600481230) Establishment Name Address ID/FEI Business Operations SASA Cosmetics 600481230 manufacture(66134-040) , api manufacture(66134-040)