ATOMY SUN SPF50 PLUS PA PLUS PLUS PLUS

Dosage form: cream
Ingredients: OCTINOXATE 4.5mL in 60mL, OCTISALATE 3mL in 60mL, ZINC OXIDE 2.88mL in 60mL, TITANIUM DIOXIDE 1.49mL in 60mL
Labeler: ATOMY CO., LTD.
NDC Code: 52257-1203

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: OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 4.8%, TITANIUM DIOXIDE 2.49%

Inactive ingredients:
WATER, CYCLOMETHICONE 5, GLYCERIN, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PHENOXYETHANOL, FRAGRANCE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHICONE, METHYLPARABEN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PROPYLPARABEN, CAMELLIA SINSENSIS LEAF EXTRACT, THYME OIL, ALTHAEA OFFICINALIS LEAF, MELISSA OFFICINALIS, BORAGO OFFICINALIS EXTRACT, CENTELLA ASIATICA, JASMINUM OFFICINALE FLOWER, PERILLA OCYMOIDES LEAF EXTRACT, BUTYLPARABEN

Purpose:
Helps prevent sunburn.
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.

Dosage and administration:
Apply liberally before sun exposure.

ATOMY SUN  SPF50 PLUS PA PLUS PLUS PLUS
octinoxate, octisalate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52257-1203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE4.5 mL  in 60 mL
OCTISALATE (OCTISALATE) OCTISALATE3 mL  in 60 mL
ZINC OXIDE (ZINC CATION) ZINC OXIDE2.88 mL  in 60 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE1.49 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
GLYCERIN 
DIPROPYLENE GLYCOL 
CYCLOMETHICONE 
PHENOXYETHANOL 
ALUMINUM HYDROXIDE 
ALUMINUM STEARATE 
METHYLPARABEN 
PROPYLPARABEN 
THYME OIL 
ALTHAEA OFFICINALIS LEAF 
MELISSA OFFICINALIS 
CENTELLA ASIATICA 
JASMINUM OFFICINALE FLOWER 
BUTYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:52257-1203-160 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/28/2010
Labeler - ATOMY CO., LTD. (631154601)
Registrant - ATOMY CO., LTD. (631154601)
Establishment
NameAddressID/FEIOperations
ATOMY CO., LTD.631154601manufacture

Revised: 02/2012
 
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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