ATOMY SUN BEIGE SPF50 PLUS PA PLUS PLUS PLUS octinoxate octisalate zinc oxide titanium dioxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

ATOMY CO., LTD.

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 4.5 mL in 60 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

ATOMY SUN BEIGE SPF50 PLUS PA PLUS PLUS PLUS - OCTINOXATE, OCTISALATE,
ZINC OXIDE,
TITANIUM DIOXIDE CREAM
ATOMY CO., LTD.
_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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DRUG FACTS
Active ingredients: OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 4.9%,
TITANIUM
DIOXIDE 2.49%
Inactive ingredients:
WATER, CYCLOMETHICONE 5, GLYCERIN, DIPROPYLENE GLYCOL, PEG-10
DIMETHICONE, CYCLOMETHICONE, TALC, DISTEARDIMONIUM HECTORITE, GREEN
TEA
LEAF, THYME OIL, MELISSA OFFICINALIS, ALTHAEA OFFICINALIS LEAF,
PERILLA
FRUTESCENS LEAF, CENTELLA ASIATICA, BORAGE, JASMINUM OFFICINALE
FLOWER,
MAGNESIUM SULFATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE
CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHICONE,
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, FRAGRANCE,
PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, IRON
OXIDES
Purpose:
Helps prevent sunburn.
Effective for sensitive skin easily prone to sun burns.
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 BEIGE SPF50 PLUS PA PLUS PLUS PLUS
octinoxate, octisalate, zinc oxide, titanium dioxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:52257-120 4
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE M