Glow Oil Spf 50

Glow Oil Spf 50
SPL v2
SPL
SPL Set ID 2a46d7d2-293f-5024-e063-6294a90a31aa
Route
TOPICAL
Published
Effective Date 2024-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (10 g) Octisalate (5 g) Homosalate
Inactive Ingredients
Diethylhexyl Syringylidenemalonate Tocopherol Soybean Oil Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Denatonium Benzoate Sunflower Oil Argan Oil Alaria Esculenta Shea Butter Grape Seed Oil Meadowfoam Seed Oil Octyldodecanol Lauryl Lactate Tert-butyl Alcohol Polyamide-3 (12000 Mw) Coconut Oil Medium-chain Triglycerides Alcohol Alkyl (c12-15) Benzoate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Isodecyl Neopentanoate Diisopropyl Sebacate Coumarin Salicylic Acid Raphanus Sativus Var. Sativus Seed Geraniol Vanillin Dipteryx Odorata Seed Triethyl Citrate .gamma.-octalactone Phenethyl Alcohol Dipterocarpus Turbinatus Wood Oil 3-hexenol Benzyl Alcohol Citrus Limon (lemon) Peel Oil Ionone Limonene, (+)- Linalool, (+)- Citral Benzyl Benzoate Citronellol Eugenol Dimethyl Heptenal Benzyl Acetate Cananga Odorata Flower Oil Methyl Anthranilate Phenylethyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-11-12

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen


Medication Information

Warnings and Precautions

Warnings

Do not use on damaged or broken skin

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

For external use only

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply
  • at least every 2 hours.
  • after 80 minutes if swimming or sweating
  • 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 your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months of age: ask a doctor.
Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% Sunscreen

Section 50565-1

Keep out of reach of children

If product is swallowed, get medical help or contact a poison Control Center right away

Section 51727-6

Caprylic/Capric Triglyceride, SD Alcohol 40-B, C12-15 Alkyl Benzoate, Octyldodecanol, Polyester-8, Polyamide-3, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Raphanus Sativus (Radish) Seed Oil, Alaria Esculenta Extract, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexyl Syringylidenemalonate, Tocopherol, Benzyl Salicylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Geraniol, Fragrance.

Section 51945-4

Supergoop!

Glow Oil SPF 50

Broad Spectrum Sunscreen SPF 50

Sunkissed Coconut / Beach Flower

Water Resistant (80 minutes) 5 fl. oz./ 148 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 Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply
  • at least every 2 hours.
  • after 80 minutes if swimming or sweating
  • 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 your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

  • Children under 6 months of age: ask a doctor.
Warnings and Precautions (34071-1)

Warnings

Do not use on damaged or broken skin

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

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children

If product is swallowed, get medical help or contact a poison Control Center right away

Section 51727-6 (51727-6)

Caprylic/Capric Triglyceride, SD Alcohol 40-B, C12-15 Alkyl Benzoate, Octyldodecanol, Polyester-8, Polyamide-3, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Raphanus Sativus (Radish) Seed Oil, Alaria Esculenta Extract, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Sebacate, Diethylhexyl Syringylidenemalonate, Tocopherol, Benzyl Salicylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Geraniol, Fragrance.

Section 51945-4 (51945-4)

Supergoop!

Glow Oil SPF 50

Broad Spectrum Sunscreen SPF 50

Sunkissed Coconut / Beach Flower

Water Resistant (80 minutes) 5 fl. oz./ 148 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 Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen


Advanced Ingredient Data


Raw Label Data

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