Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d00bffb6-a6db-410c-bc48-59125e11b8d8
Route
CUTANEOUS
Published
Effective Date 2010-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (1.65 g) Titanium (1.54 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2007-03-01
Description

Active Ingredients: ZINC OXIDE, TITANIUM DIOXIDE

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, METHYL METHACRYLATE CROSSPOLYMER, ETHYLHEXYL METHOXYCINNAMATE, BORON NITRIDE, PHENYL TRIMETHICONE, DIMETHICONE, SILICA,

ETHYLHEXYL PALMITATE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYLPARABEN, IRON OXIDES(CI 77491),

FRAGRANCE, IRON OXIDES(CI 77499), HYDROGENATED LECITHIN, BUTYLPARABEN, ROSA CANINA FLOWER, JASMINUM OFFICINALE (JASMINE) FLOWER,

ANTHEMIS NOBILIS FLOWER POWDER, PHALAENOPSIS AMABILIS EXTRACT, DENDROBIUM PHALAENOPSIS FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT,

LILIUM CANDIDUM BULB EXTRACT, IMPATIENS BALSAMINA FLOWER EXTRACT, PELARGONIUM GRAVEOLENS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT,

HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT



Section 51945-4

Section 55106-9

Active Ingredients: ZINC OXIDE, TITANIUM DIOXIDE

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, METHYL METHACRYLATE CROSSPOLYMER, ETHYLHEXYL METHOXYCINNAMATE, BORON NITRIDE, PHENYL TRIMETHICONE, DIMETHICONE, SILICA,

ETHYLHEXYL PALMITATE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYLPARABEN, IRON OXIDES(CI 77491),

FRAGRANCE, IRON OXIDES(CI 77499), HYDROGENATED LECITHIN, BUTYLPARABEN, ROSA CANINA FLOWER, JASMINUM OFFICINALE (JASMINE) FLOWER,

ANTHEMIS NOBILIS FLOWER POWDER, PHALAENOPSIS AMABILIS EXTRACT, DENDROBIUM PHALAENOPSIS FLOWER EXTRACT, CAMELLIA JAPONICA FLOWER EXTRACT,

LILIUM CANDIDUM BULB EXTRACT, IMPATIENS BALSAMINA FLOWER EXTRACT, PELARGONIUM GRAVEOLENS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT,

HIBISCUS ROSA-SINENSIS FLOWER/LEAF EXTRACT, TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredients: ZINC OXIDE, TITANIUM DIOXIDE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.802551 · Updated: 2026-03-14T22:52:25.436081