Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a22ae755-72ee-47f5-bd22-b5e15c663d27
Route
CUTANEOUS
Published
Effective Date 2010-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (0.93 g) Zinc Cation (0.17 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-07-01

Description

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Medication Information

Description

Warnings:

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts.



Directions:

Apply evenly before sun exposure and as needed.

Section 51727-6

Inactive Ingredients:



MICA(CI 77019), TALC, SILICA, SQUALANE, ALUMINA, MAGNESIUM MYRISTATE, NYLON-12, BARIUM SULFATE, BORON NITRIDE, ETHYLHEXYL METHOXYCINNAMATE, DIMETHICONE, IRON OXIDES(CI 77492), LAUROYL LYSINE?VINYL DIMETHICONE/METHICONE SILSESQUIOXANE, CROSSPOLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHICONE, MAGNESIUM STEARATE, IRON OXIDES(CI 77491), HYDROGENATED LECITHIN, METHYLPARABEN, IRON OXIDES(CI 77499), FRAGRNACE, BUTYLPARABEN, BUTYLENE GLYCOL, HYDROLYZED EXTENSIN, WATER, ULTRAMARINES(CI 77007), CROCUS SATIVUS FLOWER EXTRACT, PHENOXYETHANOL, ARTEMISIA ABROTANUM FLOWER/LEAF/STEM EXTRACT, TRIETHOXYCAPRYLYLSILANE



Section 51945-4

Section 55106-9

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Structured Label Content

Description (34089-3)

Warnings:

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts.



Directions:

Apply evenly before sun exposure and as needed.

Section 51727-6 (51727-6)

Inactive Ingredients:



MICA(CI 77019), TALC, SILICA, SQUALANE, ALUMINA, MAGNESIUM MYRISTATE, NYLON-12, BARIUM SULFATE, BORON NITRIDE, ETHYLHEXYL METHOXYCINNAMATE, DIMETHICONE, IRON OXIDES(CI 77492), LAUROYL LYSINE?VINYL DIMETHICONE/METHICONE SILSESQUIOXANE, CROSSPOLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHICONE, MAGNESIUM STEARATE, IRON OXIDES(CI 77491), HYDROGENATED LECITHIN, METHYLPARABEN, IRON OXIDES(CI 77499), FRAGRNACE, BUTYLPARABEN, BUTYLENE GLYCOL, HYDROLYZED EXTENSIN, WATER, ULTRAMARINES(CI 77007), CROCUS SATIVUS FLOWER EXTRACT, PHENOXYETHANOL, ARTEMISIA ABROTANUM FLOWER/LEAF/STEM EXTRACT, TRIETHOXYCAPRYLYLSILANE



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)