Amora Whip Screen Spf 30

Amora Whip Screen Spf 30
SPL v1
SPL
SPL Set ID 6ca148de-f597-40b2-9a31-bf9e54ff0a61
Route
TOPICAL
Published
Effective Date 2025-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (56 mg) Octocrylene (47 mg) Ethylhexyl Salicylate (38 mg) Ethylhexyl Methoxycinnamate (16 mg) Ensulizole Ci 77891
Inactive Ingredients
Water Glycerin Propylene Glycol Isododecane Stearic Acid Lauric Acid Butane Potassium Hydroxide Propane Isobutane Glyceryl Stearate Phenoxyethanol Peg-100 Stearate Silicon Dioxide Aloe Vera Leaf Sodium Citrate Ethylhexylglycerin Centella Asiatica Triterpenoids .alpha.-tocopherol Acetate Butylated Hydroxytoluene 1,2-hexanediol Hydroxyacetophenone Opuntia Ficus-indica Whole Sodium Hyaluronate Isomethyl-.alpha.-ionone Coumarin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-02

Description

Homosalate 5.6%, Octocrylene 4.7%, Octisalate 4.7%, Octinoxate 4.7%, Ensulizole 3.8%, Titanium dioxide 1.6%.


Medication Information

Warnings and Precautions

For external use only.

Skin cancer/skin aging alert • Spending time in the sun increases your risk of skin cancer and early skin aging.

• This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Indications and Usage

Helps prevent sunburn.

Dosage and Administration
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 month: ask a doctor.
Description

Homosalate 5.6%, Octocrylene 4.7%, Octisalate 4.7%, Octinoxate 4.7%, Ensulizole 3.8%, Titanium dioxide 1.6%.

Section 42229-5

Section 50565-1
  • If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • rash occurs.
Section 50567-7
  • Keep out of eyes. rinse with water to remove.
Section 50570-1
  • on damaged or broken skin.
Section 51727-6

WATER (AQUA), GLYCERIN, PROPYLENE GLYCOL, ISODODECANE, STEARIC ACID, LAURIC ACID, BUTANE, POTASSIUM HYDROXIDE, PROPANE, ISOBUTANE, GLYCERYL STEARATE, PHENOXYETHANOL, PEG-100 STEARATE, LACTOBACILLUS FERMENT, SILICA, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, FRAGRANCE (PARFUM), ETHYLHEXYLGLYCERIN, CENTELLA ASIATICA EXTRACT, SACCHAROMYCES FERMENT FILTRATE, TOCOPHERYL ACETATE, BHT, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, OPUNTIA FICUS-INDICA EXTRACT, SODIUM HYALURONATE, ALPHA- ISOMETHYL IONONE, COUMARIN.

Section 51945-4

Section 53413-1

1-212-244-5170

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 5.6%, Octocrylene 4.7%, Octisalate 4.7%, Octinoxate 4.7%, Ensulizole 3.8%, Titanium dioxide 1.6%.


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)
  • Apply generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 month: ask a doctor.
Warnings and Precautions (34071-1)

For external use only.

Skin cancer/skin aging alert • Spending time in the sun increases your risk of skin cancer and early skin aging.

• This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Section 42229-5 (42229-5)

Section 50565-1 (50565-1)
  • If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • rash occurs.
Section 50567-7 (50567-7)
  • Keep out of eyes. rinse with water to remove.
Section 50570-1 (50570-1)
  • on damaged or broken skin.
Section 51727-6 (51727-6)

WATER (AQUA), GLYCERIN, PROPYLENE GLYCOL, ISODODECANE, STEARIC ACID, LAURIC ACID, BUTANE, POTASSIUM HYDROXIDE, PROPANE, ISOBUTANE, GLYCERYL STEARATE, PHENOXYETHANOL, PEG-100 STEARATE, LACTOBACILLUS FERMENT, SILICA, ALOE BARBADENSIS LEAF JUICE, SODIUM CITRATE, FRAGRANCE (PARFUM), ETHYLHEXYLGLYCERIN, CENTELLA ASIATICA EXTRACT, SACCHAROMYCES FERMENT FILTRATE, TOCOPHERYL ACETATE, BHT, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, OPUNTIA FICUS-INDICA EXTRACT, SODIUM HYALURONATE, ALPHA- ISOMETHYL IONONE, COUMARIN.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212-244-5170

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 5.6%, Octocrylene 4.7%, Octisalate 4.7%, Octinoxate 4.7%, Ensulizole 3.8%, Titanium dioxide 1.6%.


Advanced Ingredient Data


Raw Label Data

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