Awake Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen

Awake Hello, Sunshine Moisturizer Broad Spectrum Spf 30 Sunscreen
SPL v1
SPL
SPL Set ID bbed806c-117d-ffa2-e053-2a95a90a930a
Route
TOPICAL
Published
Effective Date 2021-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 mg) Avobenzone (3 mg) Oxybenzone (1 mg) Octocrylene (10 mg) Homosalate
Inactive Ingredients
Water Dimethicone Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Phenoxyethanol Stearic Acid Butylene Glycol Squalane Phenylethyl Resorcinol Glyceryl Monostearate Glycerin Alkyl (c12-15) Benzoate Potassium Cetyl Phosphate Propanediol Cetostearyl Alcohol Polysorbate 60 Sunflower Oil Betasizofiran

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-02-22

Description

Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%.

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 50565-1

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

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

50ml, 61354-050-01

Stop Use

Stop use and ask doctor if rash occurs.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months:Ask a doctor.
  • Apply to all skin exposed to the sun.
  • 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 a.m. - 2p.m.

-Wear long-sleeved shirts, pants, hats and sunglasses

Other Information
  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to: Awake Beauty c/o Reprot Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
Active Ingredients

Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%.

Inactive Ingredients

Water, Glyceryl Stearate, Glycerin, Propanediol, Cetearyl Alcohol, Squalane, Stearic Acid,

C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Polyester-8, Polysorbate 60, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil/Helianthus Annuus Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenoxyethanol, Sclerotium Gum, Phenylethyl Resorcinol, Tribehenin, Dimethiconol, Caprylyl Glycol, Chlorphenesin, Allantoin, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Ceramide NG, PEG-10 Phytosterol, Sodium PCA, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Oligopeptide-68, Sodium Oleate, Linalool, Citral, Sodium Carbonate, Limonene, Citronellol, Geraniol, Tocopherol, Palmitoyl Hexapeptide-12, Farnesol, Mica, Titanium Dioxide, Iron Oxides.


Structured Label Content

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 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

50ml, 61354-050-01

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask doctor if rash occurs.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months:Ask a doctor.
  • Apply to all skin exposed to the sun.
  • 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 a.m. - 2p.m.

-Wear long-sleeved shirts, pants, hats and sunglasses

Other Information
  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to: Awake Beauty c/o Reprot Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
Active Ingredients

Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%.

Inactive Ingredients

Water, Glyceryl Stearate, Glycerin, Propanediol, Cetearyl Alcohol, Squalane, Stearic Acid,

C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Polyester-8, Polysorbate 60, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil/Helianthus Annuus Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenoxyethanol, Sclerotium Gum, Phenylethyl Resorcinol, Tribehenin, Dimethiconol, Caprylyl Glycol, Chlorphenesin, Allantoin, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Ceramide NG, PEG-10 Phytosterol, Sodium PCA, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Oligopeptide-68, Sodium Oleate, Linalool, Citral, Sodium Carbonate, Limonene, Citronellol, Geraniol, Tocopherol, Palmitoyl Hexapeptide-12, Farnesol, Mica, Titanium Dioxide, Iron Oxides.


Advanced Ingredient Data


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