81540-101 bring green tea tree cica sun cushion

81540-101 bring green tea tree cica sun cushion
SPL v3
SPL
SPL Set ID 30850a56-6438-dbe1-e063-6294a90a6d9f
Route
topical
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (0.8715 g) zinc oxide (2.178 g)
Inactive Ingredients
melaleuca alternifolia flowering top 1,2-hexanediol melaleuca alternifolia (tea tree) leaf oil methyl methacrylate/glycol dimethacrylate crosspolymer polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate centella asiatica triterpenoids caprylyl methicone butylene glycol dicaprylate/dicaprate disteardimonium hectorite aluminum hydroxide magnesium sulfate alcohol polyglyceryl-6 polyricinoleate ethylhexylglycerin ethylhexyl isononanoate propanediol butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) stearic acid butyloctyl salicylate diisostearyl malate melaleuca alternifolia (tea tree) leaf chromium oxide greens water methyl trimethicone triethoxycaprylylsilane tocopherol

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2025-03-20
Description

Zinc Oxide 14.52% Titanium Dioxide 5.81%

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Zinc Oxide 14.52%

Titanium Dioxide 5.81%

Indications and Usage

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 skin

Dosage and Administration

Directions

■ apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ 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 reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating

Description

Zinc Oxide 14.52% Titanium Dioxide 5.81%

Section 50565-1

■ keep out of reach of children

Section 50566-9

Stop use and ask a doctor if ■ rash occurs

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 51727-6



Water, Caprylyl Methicone, Methyl Trimethi cone, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Ethylhexyl Isononanoate, Propanediol, Diisostearyl Malate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methyl Methacrylate Cross polymer, Alcohol Denat., Acrylates Copolymer, Disteardimonium Hectorite, Magnesium Sulfate, Polyglyceryl-6 Polyricinoleate, Aluminum Hydroxide, Stearic Acid, 1,2-Hexanediol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Water, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Flower/ Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chromium Oxide Greens (CI 77288)

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)

Warnings

For external use only

Active Ingredient (55106-9)

Zinc Oxide 14.52%

Titanium Dioxide 5.81%

Indications and Usage (34067-9)

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 skin

Dosage and Administration (34068-7)

Directions

■ apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ 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 reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating

Section 50565-1 (50565-1)

■ keep out of reach of children

Section 50566-9 (50566-9)

Stop use and ask a doctor if ■ rash occurs

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 51727-6 (51727-6)



Water, Caprylyl Methicone, Methyl Trimethi cone, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, Ethylhexyl Isononanoate, Propanediol, Diisostearyl Malate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methyl Methacrylate Cross polymer, Alcohol Denat., Acrylates Copolymer, Disteardimonium Hectorite, Magnesium Sulfate, Polyglyceryl-6 Polyricinoleate, Aluminum Hydroxide, Stearic Acid, 1,2-Hexanediol, Triethoxycaprylylsilane, Ethylhexylglycerin, Tocopherol, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Water, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Flower/ Leaf/Stem Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chromium Oxide Greens (CI 77288)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:15.349260 · Updated: 2026-03-14T23:10:31.490874