SAFE SEA SPF 50- homosalate, octocrylene, octisalate, avobenzone lotion 
NIDARIA TECHNOLOGY LTD

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Safe Sea Sunscreen 50 SPF

: Active Ingredients

Octocrylene 10%

Homosalate 10%

Octisalate 5%

Avobenzone 3%

: Sunscreen Purpose

: ■ 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. Uses

: ■ ■ 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  WarningFor external use only

: ■ 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. Directions

. If product is swallowed, get medical help or  contact a Poison Control Center right away. Keep out of reach of children

: ■ 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. Other Information


: Aqua, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid Inactive Ingredients

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SAFE SEA SPF 50 
homosalate, octocrylene, octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65435-0100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LANTHANUM CHLORIDE (UNII: 04M8624OXV)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)  
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65435-0100-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/30/2021
Labeler - NIDARIA TECHNOLOGY LTD (514977487)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(65435-0100)

Revised: 11/2023
Document Id: 09c282c0-4e51-8772-e063-6294a90ae4dd
Set id: 53df3126-1136-490a-b339-5876ce89499e
Version: 6
Effective Time: 20231109
 
NIDARIA TECHNOLOGY LTD