Exel Clarifying Line Spf 50

Exel Clarifying Line Spf 50
SPL v8
SPL
SPL Set ID 0d6d4098-4121-477e-b404-3ab18628ed68
Route
TOPICAL
Published
Effective Date 2019-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octocrylene (8 g) Oxybenzone (3 g) Titanium Dioxide (5 g)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Aloe Vera Leaf Butylated Hydroxytoluene Sheanut Oil Edetate Calcium Disodium Anhydrous Medium-chain Triglycerides Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Cyclomethicone Cyclomethicone 5 Diethylamino Hydroxybenzoyl Hexyl Benzoate Dimethicone Dmdm Hydantoin Ectoine Glyceryl Stearate Se Hamamelis Virginiana Top Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Phenoxyethanol Polysorbate 20 Propylene Glycol .alpha.-tocopherol Acetate Water Xanthan Gum Yeast, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-14
Description

Active Ingredient ........ Purpose Octinoxate 7.5% ........ Sunscreen Octocrylene 8% ........ Sunscreen Oxybenzone 3% ........ Sunscreen Titanium Dioxide 5% ........ Sunscreen

Medication Information

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Children under 6 month: ask a doctor

-Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, Especially from 10 AM - 2 PMWear long-sleeved shirts, pants, hats, and sunglassesUse a water resistant sunscreen if swimming or sweating

Description

Active Ingredient ........ Purpose Octinoxate 7.5% ........ Sunscreen Octocrylene 8% ........ Sunscreen Oxybenzone 3% ........ Sunscreen Titanium Dioxide 5% ........ Sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermum Parkii (shea butter) Extract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetearyl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethlyamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (witch hazel) Extract, Iron Oxides (C.I. 77497/77492/77499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (saccharomyces cerevisiae extract)  

Section 51945-4

Exel Clarifying Line

SPF 50

Broad Spectrum SPF 50

3.30 fl.oz / 100 ml

Section 55105-1

Uses

- Helps prevent sunburn

- If used as directed with other sun protection measures (See directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 55106-9

Active Ingredient ........ Purpose

Octinoxate 7.5% ........ Sunscreen

Octocrylene 8% ........ Sunscreen

Oxybenzone 3% ........ Sunscreen

Titanium Dioxide 5% ........ Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of children. If swallowed get medical help or contact a Poison Control Center right away.

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Children under 6 month: ask a doctor

-Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, Especially from 10 AM - 2 PMWear long-sleeved shirts, pants, hats, and sunglassesUse a water resistant sunscreen if swimming or sweating

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, BHT, Butyrospermum Parkii (shea butter) Extract, Calcium Disodium EDTA, Caprylic/Capric Triglyceride, Cetearyl Alcohol (and) Ceteareth-20, Cyclomethicone, Cyclopentasiloxane, Diethlyamino Hydroxybenzoyl Hexyl Benzoate, Dimethicone, DMDM Hydantoin, Ectoin, Fragrance (Parfum), Glyceryl Stearate SE, Hamamelis Virginiana (witch hazel) Extract, Iron Oxides (C.I. 77497/77492/77499), Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium DNA, Tocopheryl Acetate, Water (Aqua), Xanthan Gum, Yeast Extract (saccharomyces cerevisiae extract)  

Section 51945-4 (51945-4)

Exel Clarifying Line

SPF 50

Broad Spectrum SPF 50

3.30 fl.oz / 100 ml

Section 55105-1 (55105-1)

Uses

- Helps prevent sunburn

- If used as directed with other sun protection measures (See directions), decreases the risk of skin cancer and early skin aging caused by the sun

Section 55106-9 (55106-9)

Active Ingredient ........ Purpose

Octinoxate 7.5% ........ Sunscreen

Octocrylene 8% ........ Sunscreen

Oxybenzone 3% ........ Sunscreen

Titanium Dioxide 5% ........ Sunscreen

Warnings (WARNINGS)

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of children. If swallowed get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.212556 · Updated: 2026-03-14T23:03:12.694901