bb0907

bb0907
SPL v4
SPL
SPL Set ID bae963c2-66ff-41c7-8122-7943505f07de
Route
topical
Published
Effective Date 2011-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (3 mL) titanium dioxide (2.15 mL) octisalate (2 mL)
Inactive Ingredients
water dimethicone cetostearyl alcohol polyglyceryl-4 isostearate hexyl laurate sodium stearoyl lactylate squalane phenoxyethanol mica methylparaben trolamine glycerin magnesium aluminum silicate propylparaben edetate trisodium vitamin a palmitate tetrahexyldecyl ascorbate triethoxycaprylylsilane hyaluronate sodium alpha-tocopherol

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
otc monograph final active Since 2010-07-26
Indications and Usage

To Use: Smooth on to face before sun exposure.

Purpose

Provides SPF 15 sun protection.

Description

For all skin types. Sheer, natural coverage. Pure, radiant finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral tinted moisturizer, infused with minerals, vitamins, and antioxidants brightens and evens out skintone with a hint of sheer, natural color. Instantly transforms skin's appearance with a fresh, luminous glow. SPF 15 sun protection. Oil free. Talc free. Fragrance free.

Medication Information

Warnings

WARNING: For external use only. Avoid contact with eyes. Discontinue use if irritation or rash appear. If irritation persists, consult a doctor. Keep out of reach of children. Clinically, dermatologist and allergy tested.

Indications and Usage

To Use: Smooth on to face before sun exposure.

Purpose

Provides SPF 15 sun protection.

Description

For all skin types. Sheer, natural coverage. Pure, radiant finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral tinted moisturizer, infused with minerals, vitamins, and antioxidants brightens and evens out skintone with a hint of sheer, natural color. Instantly transforms skin's appearance with a fresh, luminous glow. SPF 15 sun protection. Oil free. Talc free. Fragrance free.

Otc Purpose

Provides SPF 15 sun protection.

Otc When Using

Avoid contact with eyes.

Inactive Ingredient

Other Ingredients: Water/Aqua/Eau, Dimethicone, Mica, Cetearyl Alcohol, Polyglyceryl-4 Isostearate, Cetyl Dimethicone, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Stearoyl Lactylate, Squalane, Hydrogenated Polyisobutene, Silene Uniflora Extract, Sodium Hyaluronate, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Jojoba Esters, Glycerin, Triethoxycaprylylsilane, Carbomer, Magnesium Aluminum Silicate, Triethanolamine, Trisodium EDTA, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Dosage & Administration

Smooth on to face.

Otc Active Ingredient

Active Ingredients: Octinoxate 6.0%, Titanium Dioxide 4.3%, Octisalate 4.0%.

Otc Keep Out of Reach of Children

Keep out of reach of children.

Package Label.principal Display Panel

Structured Label Content

Warnings (WARNINGS)

WARNING: For external use only. Avoid contact with eyes. Discontinue use if irritation or rash appear. If irritation persists, consult a doctor. Keep out of reach of children. Clinically, dermatologist and allergy tested.

Indications and Usage (INDICATIONS AND USAGE)

To Use: Smooth on to face before sun exposure.

Description (DESCRIPTION)

For all skin types. Sheer, natural coverage. Pure, radiant finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral tinted moisturizer, infused with minerals, vitamins, and antioxidants brightens and evens out skintone with a hint of sheer, natural color. Instantly transforms skin's appearance with a fresh, luminous glow. SPF 15 sun protection. Oil free. Talc free. Fragrance free.

Otc Purpose (OTC - PURPOSE)

Provides SPF 15 sun protection.

Otc When Using (OTC - WHEN USING)

Avoid contact with eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Other Ingredients: Water/Aqua/Eau, Dimethicone, Mica, Cetearyl Alcohol, Polyglyceryl-4 Isostearate, Cetyl Dimethicone, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Stearoyl Lactylate, Squalane, Hydrogenated Polyisobutene, Silene Uniflora Extract, Sodium Hyaluronate, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Jojoba Esters, Glycerin, Triethoxycaprylylsilane, Carbomer, Magnesium Aluminum Silicate, Triethanolamine, Trisodium EDTA, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Dosage & Administration (DOSAGE & ADMINISTRATION)

Smooth on to face.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate 6.0%, Titanium Dioxide 4.3%, Octisalate 4.0%.

Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:17.144594 · Updated: 2026-03-14T22:52:42.374916