Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2eda1a2b-e024-449b-9553-839cdad9aab3
Route
TOPICAL
Published
Effective Date 2010-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.05 mL) Octinoxate (0.07 mL) Enzacamene (0.03 mL) Avobenzone (0.005 mL)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2010-08-04

Description

Active Ingredients: Ethylhexyl Methoxycinnamate, Zinc Oxide, 4-Methylbenzylidene camphor, Butyl Mehoxydibenzoylmethane


Medication Information

Description
Uses

■ Perfectly blocks both UVA and UVB rays without stimuli

■ Provides high protection from sunburn

■ Suitable for skin that underwent medical treatment



Warning

For external use only

When using this product

■    Avoid eye area. If contact occurs, rinse eyes thoroughly

■  Discontinue use if signs of irritation develops

Keep out of reach of the children



Direction

■ Rub a proper quantity over the whole face, before finishing skincare.



Other Information

■ store between 20-25 °C (68-77 °F)

■ avoid freezing and excessive heat above 40 °C (104 °F)

■ close cap after use.



Inactive Ingredient

■ Water ■ Cyclomethicone ■ Dimethicone/Vinyl Dimethicone Crosspolymer ■ C12-15 Alkyl Benzoate ■ Glycerin ■ Cetyl PEG/PPG-10/1 Dimethicone ■ Beeswax ■ Sodium Chloride ■ Sorbitan Sesquiolate ■ C20-40 acid ■ Methylparaben ■ Polyethylene ■ Brassica Campestris Sterols ■ Propylparaben ■ Disodium EDTA



Section 51945-4
Section 55106-9
Active Ingredients: Ethylhexyl Methoxycinnamate, Zinc Oxide, 4-Methylbenzylidene camphor, Butyl Mehoxydibenzoylmethane

Structured Label Content

Description (34089-3)
Uses

■ Perfectly blocks both UVA and UVB rays without stimuli

■ Provides high protection from sunburn

■ Suitable for skin that underwent medical treatment



Warning

For external use only

When using this product

■    Avoid eye area. If contact occurs, rinse eyes thoroughly

■  Discontinue use if signs of irritation develops

Keep out of reach of the children



Direction

■ Rub a proper quantity over the whole face, before finishing skincare.



Other Information

■ store between 20-25 °C (68-77 °F)

■ avoid freezing and excessive heat above 40 °C (104 °F)

■ close cap after use.



Inactive Ingredient

■ Water ■ Cyclomethicone ■ Dimethicone/Vinyl Dimethicone Crosspolymer ■ C12-15 Alkyl Benzoate ■ Glycerin ■ Cetyl PEG/PPG-10/1 Dimethicone ■ Beeswax ■ Sodium Chloride ■ Sorbitan Sesquiolate ■ C20-40 acid ■ Methylparaben ■ Polyethylene ■ Brassica Campestris Sterols ■ Propylparaben ■ Disodium EDTA



Section 51945-4 (51945-4)
Section 55106-9 (55106-9)
Active Ingredients: Ethylhexyl Methoxycinnamate, Zinc Oxide, 4-Methylbenzylidene camphor, Butyl Mehoxydibenzoylmethane

Advanced Ingredient Data


Raw Label Data

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