Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ffa53d3f-0dfb-4f2e-a831-cc3085c3ef3b
Route
TOPICAL
Published
Effective Date 2011-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5.80 mL) Octinoxate (5 mL)
Inactive Ingredients
Water Cyclomethicone 5 Butylene Glycol Hexyl Laurate Polysorbate 60 Squalane Glycerin Biosaccharide Gum-1 Phenoxyethanol Ferric Oxide Yellow Methylparaben Talc Ferric Oxide Red Ethylparaben Ferrosoferric Oxide Triethoxycaprylylsilane Poncirus Trifoliata Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-08-23
Description

TITANIUM DIOXIDE (5.8%) OCTINOXATE (5%)

Medication Information

Dosage and Administration

Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)

Description

TITANIUM DIOXIDE (5.8%) OCTINOXATE (5%)

Section 50566-9

Discontinue use if sign of irritation or rash appear.

Section 50567-7
Avoid contact with eyes.
Section 51727-6
WATER, CYCLOMETHICONE 5, BUTYLENE GLYCOL, HEXYL LAURATE, POLYSORBATE 60, SQUALANE, GLYCERIN, BIOSACCHARIDE GUM-1, PHENOXYETHANOL, FERRIC OXIDE YELLOW, METHYLPARABEN, TALC, FERRIC OXIDE RED, ETHYLPARABEN, FERROSOFERRIC OXIDE, TRIETHOXYCAPRYLYLSILANE, BUTYLENE GLYCOL, PONCIRUS TRIFOLIATA FRUIT

Section 51945-4
FACE IT AQUA TINTED BB SPF 20 PA 01





Section 55105-1

Provides high protection against sunburn and tanning.

Section 55106-9
TITANIUM DIOXIDE (5.8%)

OCTINOXATE (5%)

Structured Label Content

Dosage and Administration (34068-7)

Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)

Section 50566-9 (50566-9)

Discontinue use if sign of irritation or rash appear.

Section 50567-7 (50567-7)
Avoid contact with eyes.
Section 51727-6 (51727-6)
WATER, CYCLOMETHICONE 5, BUTYLENE GLYCOL, HEXYL LAURATE, POLYSORBATE 60, SQUALANE, GLYCERIN, BIOSACCHARIDE GUM-1, PHENOXYETHANOL, FERRIC OXIDE YELLOW, METHYLPARABEN, TALC, FERRIC OXIDE RED, ETHYLPARABEN, FERROSOFERRIC OXIDE, TRIETHOXYCAPRYLYLSILANE, BUTYLENE GLYCOL, PONCIRUS TRIFOLIATA FRUIT

Section 51945-4 (51945-4)
FACE IT AQUA TINTED BB SPF 20 PA 01





Section 55105-1 (55105-1)

Provides high protection against sunburn and tanning.

Section 55106-9 (55106-9)
TITANIUM DIOXIDE (5.8%)

OCTINOXATE (5%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:19.621611 · Updated: 2026-03-14T22:52:49.153069