SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion 
Capsule Corporation

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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Sunscreen lotion Broad Spectrum SPF 30

Drug Facts

Active Ingredient

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Purpose

Sunscreen

Uses

Warnings

Do not use

  • on damaged or broken skin.

When using this product

keep out of eyes

- rinse with water to remove.

Stop use and consult physician

  • if irritation or rash develops.

Keep out of reach of children

- if product is swallowed, get medical attention or contact poison control center immediately.

Directions

Inactive Ingredients

Do not store in excessive heat or direct sunlight.

Package Labeling:

Bottle2

SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70469-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CARROT (UNII: L56Z1JK48B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
SOYBEAN OIL (UNII: 241ATL177A)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALMOND OIL (UNII: 66YXD4DKO9)  
SESAME OIL (UNII: QX10HYY4QV)  
COCOA (UNII: D9108TZ9KG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70469-142-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/25/2020
Labeler - Capsule Corporation (079920193)

Revised: 6/2020
Document Id: a7e23e24-6c67-d2c9-e053-2a95a90a231e
Set id: 9c084eb9-91b0-49be-9830-19c8920d4b21
Version: 1
Effective Time: 20200612
 
Capsule Corporation