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

Safe Sea SPF 40 by

Drug Labeling and Warnings

Safe Sea SPF 40 by is a Otc medication manufactured, distributed, or labeled by NIDARIA TECHNOLOGY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients                                                                   Purpose

Octocrylene 10%                                                                     Sunscreen

Homosalate 10%                                                                     Sunscreen

Octisalate 5%                                                                          Sunscreen

Avobenzone 3%                                                                       Sunscreen

PURPOSE

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.
• 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

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.

Inactive ingredients

C12-15 Alkyl Benzoate, Calcium Chloride, Cetyl Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dibutyl Adipate, Dicetyl Phthalate, Dimethicone, Fragrance, Glycoproteins, Glycosaminoglycans, Hydrogenated Castor Oil, Laureth-9, PEG/PPG-18/18 Methicone, Magnesium Chloride, Panthenol, PEG-30 Dipolyhydroxystearate, Plankton Extract, Propanediol, Stearyl Dimethicone, Tocopheryl Acetate, VP/Hexadecene Copolymer, Water.

Product label

INGREDIENTS AND APPEARANCE

SAFE SEA SPF 40 
octocrylene, homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65435-0300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
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)
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
PROPANEDIOL (UNII: 5965N8W85T)
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)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65435-0300-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2021

Labeler - NIDARIA TECHNOLOGY LTD (514977487)