In Transit Skin Defence

In Transit Skin Defence
SPL v7
SPL
SPL Set ID c3425525-df4d-403b-ac7a-84067f030118
Route
TOPICAL
Published
Effective Date 2019-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (70 mg) Octocrylene (95 mg) Oxybenzone (60 mg)
Inactive Ingredients
Water Shea Butter Glycerin Butylene Glycol Octyldodecanol Starch, Tapioca Phenoxyethanol Medium-chain Triglycerides Cyclomethicone 5 Glyceryl Stearate Se Stearic Acid Xylitylglucoside Benzyl Alcohol Sodium Stearoyl Glutamate Anhydroxylitol Xanthan Gum Echium Plantagineum Seed Oil Xylitol C13-14 Isoparaffin Edetate Disodium Anhydrous Hyaluronate Sodium Cocoa Butter .alpha.-tocopherol Acetate Helianthus Annuus Flowering Top Polymethylsilsesquioxane (4.5 Microns) Dehydroacetic Acid Laureth-7 Limonene, (+)- Ethylbisiminomethylguaiacol Manganese Chloride Cardiospermum Halicacabum Flowering Top Linalool, (+/-)- Tocopherol Citrus Aurantium Leafy Twig Oil Bergamot Oil Lemon Oil Juniperus Virginiana Oil Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-05-17
Description

Avobenzone 3% Octinoxate 7% Octocrylene 9.5% Oxybenzone 6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octinoxate 7% Octocrylene 9.5% Oxybenzone 6%

Use
  • Helps prevent sunburn.
Section 53413-1

To report serious adverse even contact This Works Products Limited on 855-877-0555.

Warnings

For external use only.

Drug Facts

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10am to2pm.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Do Not Use 

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%

Octinoxate 7%

Octocrylene 9.5%

Oxybenzone 6%

Inactive Ingredients

Aqua (Water/Eau), Butyrospermum parkii (Shea) butter, Acacia decurrens/Jojoba/Sunflower seed cera (Wax/Cire)/Polyglyceryl-3 esters, Glycerin, Butylene glycol, Octyldodecanol, Tapioca starch, Phenoxyethanol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Glyceryl stearate SE, Stearic acid, Xylitylglucoside, Benzyl alcohol, Sodium stearoyl glutamate, Anhydroxylitol, Polyacrylamide, Xanthan gum, Echium plantagineum seed oil, Lecithin, Xylitol, C13-14 Isoparaffin, Disodium EDTA, Sodium hyaluronate, Theobroma cacao (Cocoa) seed butter, Tocopheryl acetate, Helianthus annuus (Sunflower) seed oil unsaponifiables, Polymethylsilsesquioxane, Dehydroacetic acid, Parfum (Fragrance), Laureth-7, Limonene, Ethylbisiminomethylguaiacol manganese chloride, Cardiospermum halicacabum flower/Leaf/Vine extract, Linalool, Tocopherol, Citrus aurantium amara (Bitter Orange) leaf/Twig oil, Citrus aurantium bergamia (Bergamot) peel oil, Citrus limon (Lemon) peel oil, juniperus virginiana (Cedarwood) wood oil, Citric acid. *Naturally occuring i essential oils.

Stop Use and Ask A Doctor

if rash occurs.

When Using This Product 

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Structured Label Content

Use
  • Helps prevent sunburn.
Section 53413-1 (53413-1)

To report serious adverse even contact This Works Products Limited on 855-877-0555.

Purpose

Sunscreen

Warnings

For external use only.

Drug Facts (DRUG FACTS)

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10am to2pm.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.
Do Not Use  (Do not use )

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Avobenzone 3%

Octinoxate 7%

Octocrylene 9.5%

Oxybenzone 6%

Inactive Ingredients

Aqua (Water/Eau), Butyrospermum parkii (Shea) butter, Acacia decurrens/Jojoba/Sunflower seed cera (Wax/Cire)/Polyglyceryl-3 esters, Glycerin, Butylene glycol, Octyldodecanol, Tapioca starch, Phenoxyethanol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Glyceryl stearate SE, Stearic acid, Xylitylglucoside, Benzyl alcohol, Sodium stearoyl glutamate, Anhydroxylitol, Polyacrylamide, Xanthan gum, Echium plantagineum seed oil, Lecithin, Xylitol, C13-14 Isoparaffin, Disodium EDTA, Sodium hyaluronate, Theobroma cacao (Cocoa) seed butter, Tocopheryl acetate, Helianthus annuus (Sunflower) seed oil unsaponifiables, Polymethylsilsesquioxane, Dehydroacetic acid, Parfum (Fragrance), Laureth-7, Limonene, Ethylbisiminomethylguaiacol manganese chloride, Cardiospermum halicacabum flower/Leaf/Vine extract, Linalool, Tocopherol, Citrus aurantium amara (Bitter Orange) leaf/Twig oil, Citrus aurantium bergamia (Bergamot) peel oil, Citrus limon (Lemon) peel oil, juniperus virginiana (Cedarwood) wood oil, Citric acid. *Naturally occuring i essential oils.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:20.794931 · Updated: 2026-03-14T23:01:50.647319