ATOMY MINERAL PACT SPF35 PA PLUS PLUS NO.25

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 2.20g in 12g, ZINC OXIDE 0.23g in 12g
Labeler: ATOMY CO., LTD.
NDC Code: 52257-1205

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.

Drug Facts

Active ingredients: TITANIUM DIOXIDE 18.320%, ZINC OXIDE 1.920%

Inactive ingredients:
MICA, TALC, SILICA, DIMETHICONE, BORON NITRIDE, DIISOSTEARYL MALATE, TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE, NYLON-12, METHYL METHACRYLATE CROSSPOLYMER, TRIETHYLHEXANOIN, TRIETHOXYCAPRYLYLSILANE, PHENYL TRIMETHICONE, TOCOPHERYL ACETATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, METHICONE, GLYCERYL CAPRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, POLYGLYCERYL-2 TETRAISOSTEARATE, ALUMINUM MYRISTATE, CAPRYLYL GLYCOL, ALUMINUM HYDROXIDE, DISODIUM STEAROYL GLUTAMATE, TRIMETHYLSILOXYSILICATE, MYRISTIC ACID, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, ALUMINUM DIMYRISTATE, C9-15 FLUOROALCOHOL PHOSPHATE, ALUMINA, ZEA MAYS (CORN) STARCH, CALCIUM CARBONATE, HYDROXYAPATITE, ROYAL JELLY, PISTACIA LENTISCUS (MASTIC) GUM, WATER, PROPOLIS WAX, WATER, ACETYL HEXAPEPTIDE-8, FRAGRANCE, IRON OXIDES

Purpose:
Helps prevent sunburn.
Provides moderate protection against adverse effects of the sun.
Higher SPF gives more sunburn protection.
Effective for the skin highly sensitive to sunburn.

Warnings:
For external use only.
UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage.
It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using a sunscreen.
When using this product,  keep out of eyes. Rinse water to remove.
Stop use and ask a doctor, if rash or irritation develops and lasts.

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

Indication and usage:
- Children under 6months of age: ask a doctor.
- Reapply as needed or after towel drying, swimming or perspiring.
- Not intended for protection while sunbathing.

Dosage and administration:
Apply liberally before sun exposure.

ATOMY MINERAL PACT  SPF35 PA PLUS PLUS NO.25
titanium dioxide, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1205
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE2.20 g  in 12 g
ZINC OXIDE (ZINC CATION) ZINC OXIDE0.23 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
MICA 
TALC 
DIMETHICONE 
BORON NITRIDE 
PHENYL TRIMETHICONE 
WATER 
GLYCERYL CAPRYLATE 
CAPRYLYL GLYCOL 
ALUMINUM HYDROXIDE 
DISODIUM STEAROYL GLUTAMATE 
MYRISTIC ACID 
ALUMINUM DIMYRISTATE 
PROPOLIS WAX 
CALCIUM CARBONATE 
Packaging
#Item CodePackage Description
1NDC:52257-1205-112 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/29/2010
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIOperations
ATOMY CO., LTD.631154601manufacture

Revised: 03/2012
 
ATOMY CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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