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 INGREDIENT

Active Ingredients:

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

Purpose: Sunscreen

PURPOSE

INACTIVE INGREDIENT

Inactive Ingredients: Aqua, Dibutyl Adipate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Dicaprylyl Ether, PEG-30 Dipolyhydroxystearate, Lauryl PEG/PPG-18/18 Methicone, Isopropyl Myristate, Stearyl Dimethicone, Cetyl dimethicone, Propanediol, VP/Hexadecene Copolymer, Panthenol, Tocopheryl Acetate, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Plankton-Extract, Glycoproteins, Glycosaminoglycans, Parfum, Chlorphenesin.

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 use and ask a doctor if rash occurs.

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) & Rhopilema. Data on file. ■ Protect this product from excessive heat and direct sun.

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
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)
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)

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)