73877-006_cica redness solution sunscreen

73877-006_cica redness solution sunscreen
SPL v2
SPL
SPL Set ID 15eea1eb-9468-4611-915d-e43112c4a4f5
Route
topical
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (170 mg)
Inactive Ingredients
water cyclopentasiloxane butylene glycol isododecane butyloctyl salicylate titanium dioxide trimethylsiloxysilicate (m/q 0.6-0.8) caprylyl trisiloxane butylene glycol dicaprylate/dicaprate magnesium potassium aluminosilicate fluoride tridecyl trimellitate pentylene glycol disteardimonium hectorite magnesium sulfate, unspecified form lauryl peg-8 dimethicone (300 cps) ferric oxide yellow triethoxycaprylylsilane caprylyl glycol glyceryl monocaprylate chromic oxide ferric oxide red zein ferrosoferric oxide ethylhexylglycerin aluminum hydroxide silica dimethyl silylate starch, corn hydrogenated soybean lecithin medium-chain triglycerides glycerin tocopherol nelumbo nucifera flower oil 1,2-hexanediol centella asiatica triterpenoids fig inonotus obliquus fruiting body calendula officinalis flower taraxacum officinale leaf citrus australasica whole ceramide np

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-12

Description

Zinc Oxide 17%


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 rash occurs.

Active Ingredient

Zinc Oxide 17%

Indications and Usage

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.

Dosage and Administration

For sunscreen use:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every two 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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

- Children under 6 months of age: Ask a doctor.

Description

Zinc Oxide 17%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, ISODODECANE, BUTYLOCTYL SALICYLATE, TITANIUM DIOXIDE (CI 77891), TRIMETHYLSILOXYSILICATE, CAPRYLYL METHICONE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, BUTYLENE GLYCOL, DICAPRYLATE/DICAPRATE, SYNTHETIC FLUORPHLOGOPITE, TRIDECYL TRIMELLITATE, PENTYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, LAURYL PEG-8 DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, CHROMIUM OXIDE GREENS, IRON OXIDES(CI 77491), ZEIN, IRON OXIDES(CI 77499), ETHYLHEXYLGLYCERIN, ALUMINUM HYDROXIDE, SILICA, DIMETHYL SILYLATE, FRAGRANCE, ZEA MAYS (CORN) STARCH, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, TOCOPHEROL, NELUMBO NUCIFERA FLOWER WATER, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT, MICROCITRUS AUSTRALASICA FRUIT EXTRACT, CERAMIDE NP

Section 51945-4

Section 55105-1

Sunscreen

Section 60561-8

Protect the product in this container from excessive heat and direct sun


Structured Label Content

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 rash occurs.

Active Ingredient (55106-9)

Zinc Oxide 17%

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

For sunscreen use:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every two 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: 1) Limit time in the sun, especially from 10 a.m. to 2 p.m. 2) Wear long-sleeved shirts, pants, hats, and sunglasses

- Children under 6 months of age: Ask a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, ISODODECANE, BUTYLOCTYL SALICYLATE, TITANIUM DIOXIDE (CI 77891), TRIMETHYLSILOXYSILICATE, CAPRYLYL METHICONE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, BUTYLENE GLYCOL, DICAPRYLATE/DICAPRATE, SYNTHETIC FLUORPHLOGOPITE, TRIDECYL TRIMELLITATE, PENTYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, LAURYL PEG-8 DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, CHROMIUM OXIDE GREENS, IRON OXIDES(CI 77491), ZEIN, IRON OXIDES(CI 77499), ETHYLHEXYLGLYCERIN, ALUMINUM HYDROXIDE, SILICA, DIMETHYL SILYLATE, FRAGRANCE, ZEA MAYS (CORN) STARCH, HYDROGENATED LECITHIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, TOCOPHEROL, NELUMBO NUCIFERA FLOWER WATER, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, TARAXACUM OFFICINALE (DANDELION) LEAF EXTRACT, MICROCITRUS AUSTRALASICA FRUIT EXTRACT, CERAMIDE NP

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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