Alba Botanica Sheer Minieal Spf 50

Alba Botanica Sheer Minieal Spf 50
SPL v3
SPL
SPL Set ID f4a02196-288e-1958-e053-2a95a90a5305
Route
TOPICAL
Published
Effective Date 2018-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Ethylhexylglycerin Potassium Cetyl Phosphate Water Phenoxyethanol Hexasodium Phytate Glycerin .alpha.-tocopherol Acetate Xanthan Gum Alcohol Ethylhexyl Oleate Butyloctyl Salicylate Vinylpyrrolidone/hexadecene Copolymer Caprylic/capric Acid Glyceryl Stearate Se Isoamyl Laurate Niacinamide Polyhydroxystearic Acid (2300 Mw) Squalane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Zinc Oxide 25% (w/w)


Medication Information

Warnings and Precautions

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 skin rash occurs.

Indications and Usage

Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

Dosage and Administration

Apply liberally 15 minutes before sun exposure. Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours. Children under 6 months of age: ask a doctor.

Description

Zinc Oxide 25% (w/w)

Section 50565-1

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

Section 51727-6

Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate SE, Niacinamide, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Xanthan Gum, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol

(1) Certified Organic Ingredient

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 25% (w/w)


Structured Label Content

Indications and Usage (34067-9)

Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure. Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours. Children under 6 months of age: ask a doctor.

Warnings and Precautions (34071-1)

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 skin rash occurs.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water (Aqua), Caprylic/Capric Triglyceride, Ethylhexyl Olivate, Butyloctyl Salicylate, Isoamyl Laurate, Glyceryl Stearate SE, Niacinamide, VP/Hexadecene Copolymer, Triethoxycaprylylsilane, Tocopheryl Acetate, Glycerin, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Sodium Phytate, Squalane, Xanthan Gum, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol

(1) Certified Organic Ingredient

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 25% (w/w)


Advanced Ingredient Data


Raw Label Data

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