Protec(tint) Spf 50

SPL v2

SPL

SPL Set ID 0801287f-0df5-4303-e063-6394a90a503b

Route

TOPICAL

Published

Effective Date 2023-11-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Homosalate (7 g) Zinc Oxide (13.58 g) Octisalate (5 g)

Inactive Ingredients

Tocopherol Ferric Oxide Yellow Ferric Oxide Red Isononyl Isononanoate Glycerin Noni Fruit Phytate Sodium Ferrosoferric Oxide Polyhydroxystearic Acid (2300 Mw) Xanthan Gum Hyaluronate Sodium Titanium Dioxide Propanediol Cetostearyl Alcohol Lauryl Glucoside Polyglyceryl-2 Dipolyhydroxystearate Ammonium Acryloyldimethyltaurate/vp Copolymer Coco Glucoside Water 1,2-hexanediol Lecithin, Sunflower Coco-caprylate/caprate Triethoxycaprylylsilane Bentonite Butyloctyl Salicylate Silicon Dioxide Ectoine Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance

Color: white Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-22

Description

Active Ingredients: Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%

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

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

Use a water resistant sunscreen 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 time in the sun, especially from 10 a.m.- 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Description

Active Ingredients: Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%

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

Inactive Ingredients:IAqua/Water/Eau, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Silica, Glycerin,1,2-Hexanediol, Lecithin, Coco-Caprylate/Caprate, Cetearyl Alcohol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ectoin, Coco-Glucoside, Polyhydroxystearic acid, Citric Acid, Triethoxycaprylylsilane, Morinda Citrifolia Extract, Xanthan Gum, Sodium Phytate, Bentonite, Sodium Hyaluronate, Tocopherol

Section 51945-4

Protec(tint)

Daily SPF Tint

SPF 50

Broad Spectrum Tinted

Sunscreen SPF 50

1.18 fl. oz. / 35 ml.

SHADE LABELS

Section 55105-1

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: Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%

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

Use a water resistant sunscreen if swimming or sweating

Limit time in the sun, especially from 10 a.m.- 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: 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

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)

Section 51945-4 (51945-4)

Protec(tint)

Daily SPF Tint

SPF 50

Broad Spectrum Tinted

Sunscreen SPF 50

1.18 fl. oz. / 35 ml.

SHADE LABELS

Section 55105-1 (55105-1)

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: Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%

Advanced Ingredient Data

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{"34067-9": "Stop use and ask a doctor if rash occurs", "34068-7": "Directions Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen 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 time in the sun, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor", "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", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.", "51727-6": "Inactive Ingredients: IAqua/Water/Eau, Isononyl Isononanoate, Butyloctyl Salicylate, Propanediol, Silica, Glycerin,1,2-Hexanediol, Lecithin, Coco-Caprylate/Caprate, Cetearyl Alcohol, Lauryl Glucoside, Polyglyceryl-2 Dipolyhydroxystearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ectoin, Coco-Glucoside, Polyhydroxystearic acid, Citric Acid, Triethoxycaprylylsilane, Morinda Citrifolia Extract, Xanthan Gum, Sodium Phytate, Bentonite, Sodium Hyaluronate, Tocopherol", "51945-4": "Protec(tint) Daily SPF Tint SPF 50 Broad Spectrum Tinted Sunscreen SPF 50 1.18 fl. oz. / 35 ml. SHADE LABELS", "55105-1": "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", "55106-9": "Active Ingredients: Zinc Oxide 13.58%, Homosalate 7.0%, Octisalate 5.0%"}

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Source: dailymed · Ingested: 2026-02-15T12:02:23.682119 · Updated: 2026-03-14T23:12:56.390264