POWDER- zinc oxide, titanium dioxide powder 
Oxygen development

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SEA SET & PROTECT MINERAL POWDER SUNSCREEN BROAD SPECTRUM SPF 30 TRASLUCENT

Active ingredients

Titanium Dioxide 8.6%

Zinc Oxide 10.0%

Purpose

Sunscreen

Uses

Warnings

For external use only

Stop Use

Stop use and ask doctor if rash occurs

Do not use

Do not use on damaged or broken skin

When using

When using this product keep out of eyes. Rinse with water to remove

Keep out of the reach of children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control center rigth away

Directions

Other information

Inactive Ingredients

Polymethylsilsesquioxane, silica, jojoba esters, caprylyl glycol, alumina, sodium dehydroacetate, phenoxyethanol, vanillin, caprylic/capric triglyceride, hexylene glycol, vanilla planifolia fruit extract, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, mica, iron oxides. OX100FW000041.

Primary package

61354-052-03_AW 8g 61354-052-03

Secondary Package

61354-052-03_AW8g 61354-052-03

POWDER 
zinc oxide, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.6 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-052-031 in 1 CARTON02/25/2021
18 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/25/2021
Labeler - Oxygen development (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development137098492manufacture(61354-052)

Revised: 2/2023
Document Id: f45d03b3-a13a-43ea-e053-2a95a90ab892
Set id: bc2cca08-4133-4d07-e053-2995a90ab269
Version: 2
Effective Time: 20230210
 
Oxygen development