SPL v24
SPL
SPL Set ID 3cdf06f2-63f2-7a59-e063-6294a90a72ea
Route
CUTANEOUS
Published
Effective Date 2025-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.5 g) Zinc Oxide (6 g)
Inactive Ingredients
Sodium Pca Glyceryl Stearate Aluminum Hydroxide Sodium Hyaluronate Fullerenes Stearic Acid Panthenol Sodium Acetylated Hyaluronate Cetearyl Alcohol Bisabolol Pentaerythrityl Tetraethylhexanoate Green Tea Leaf Ascorbyl Glucoside Potassium Cetyl Phosphate Bis-ethylhexyloxyphenol Methoxyphenyl Triazine Niacinamide Water Ethylhexyl Palmitate Cetyl Ethylhexanoate Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-24
Description

Active Ingredients Purpose Zinc Oxide . 6.0% … .SunscreenTitanium Dioxide .... 4.5%sunscreen

Medication Information

Warnings and Precautions



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Indications and Usage



USES:

Helps prevent sunburn. If used as directed withother sun protection measures (see Directions)it helps minimize signs of UVinduced skin

agig.

Dosage and Administration



USES:

Helps prevent sunburn. If used as directed withother sun protection measures (see Directions)it helps minimize signs of UVinduced skin

agig.

Description

Active Ingredients Purpose Zinc Oxide . 6.0% … .SunscreenTitanium Dioxide .... 4.5%sunscreen

Section 50565-1



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 50566-9



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 50567-7



USES:

Helps prevent sunburn. If used as directed withother sun protection measures (see Directions)it helps minimize signs of UVinduced skin

agig.

Section 50570-1



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 51727-6



INACTIVE INGREDIENTS:Water, Ethylhexyl Palmitate, CetylEthylhexanoate, Tinosorb S(Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine)Butyloctyl Salicylate, PentaerythritylTetraethylhexanoate, Potassium CetylPhosphate, Cetearyl Alcohol, Hemisqualane,Silica, Glyceryl Stearate, Sodium PCA,Panthenol, Niacinamide, Ascorbyl Glucoside,Sodium Hyaluronate, Acetylated SodiumHyaluronate, Cross-linked Sodium Hyaluronate,Hydrolyzed Sodium Hyaluronate, PolypodiumLeucotomos Extract, Green Tea Extract,Fullerene, Collagen Peptide, Pro-Xylane,Tri(Cetearyl-4) Phosphate, AluminumHydroxide, Stearic Acid, Tocopheryl Acetate,

Natural Bisabolol

Section 51945-4

GREEN TEAHydraShield SPF 50MoisturizerHIGH PROTECTIONUVA UVB PA++++

DRUG FACTTS

Active Ingredients Purpose

Zinc Oxide .. 6.0% . SunscreenTitanium Dioxide . 4.5%.Sunscreen

USES:

Helps prevent sunburn, If used as directed withother sun protection measures (see Directions),it helps minimize signs of UV-induced skin

aging

WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. Keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away



OTHER INFORMATIONStore at 15-40°C(59-104°F).Keep containertightly closed and avoid extreme heat or directsun exposure.

INACTIVE INGREDIENTS:

Water, Ethylhexyl Palmitate, CetylEthylhexanoate, Tinosorb S (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine),Butyloctyl Salicylate, PentaerythritylTetraethylhexanoate, Potassium Cetyl

Phosphate, Cetearyl Alcohol, Hemisqualane,Silica, Glyceryl Stearate, Sodium PCA,Panthenol, Niacinamide, Ascorbyl Glucoside,Sodium Hyaluronate, Acetylated SodiumHyaluronate, Cross-linked Sodium Hyaluronate,Hydrolyzed Sodium Hyaluronate, PolypodiumLeucotomos Extract, Green Tea Extract,Fullerene, Collagen Peptide, Pro-Xylane,Tri(Cetearyl-4)Phosphate, AluminumHydroxide, Stearic Acid, Tocopheryl Acetate,

Natural Bisabolol

Section 55105-1



HIGH PROTECTION

UVA UVB PA++++

Section 55106-9



Active Ingredients Purpose

Zinc Oxide . 6.0% … .SunscreenTitanium Dioxide .... 4.5%sunscreen

Structured Label Content

Indications and Usage (34067-9)



USES:

Helps prevent sunburn. If used as directed withother sun protection measures (see Directions)it helps minimize signs of UVinduced skin

agig.

Dosage and Administration (34068-7)



USES:

Helps prevent sunburn. If used as directed withother sun protection measures (see Directions)it helps minimize signs of UVinduced skin

agig.

Warnings and Precautions (34071-1)



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 50565-1 (50565-1)



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 50566-9 (50566-9)



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 50567-7 (50567-7)



USES:

Helps prevent sunburn. If used as directed withother sun protection measures (see Directions)it helps minimize signs of UVinduced skin

agig.

Section 50570-1 (50570-1)



WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away.

Section 51727-6 (51727-6)



INACTIVE INGREDIENTS:Water, Ethylhexyl Palmitate, CetylEthylhexanoate, Tinosorb S(Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine)Butyloctyl Salicylate, PentaerythritylTetraethylhexanoate, Potassium CetylPhosphate, Cetearyl Alcohol, Hemisqualane,Silica, Glyceryl Stearate, Sodium PCA,Panthenol, Niacinamide, Ascorbyl Glucoside,Sodium Hyaluronate, Acetylated SodiumHyaluronate, Cross-linked Sodium Hyaluronate,Hydrolyzed Sodium Hyaluronate, PolypodiumLeucotomos Extract, Green Tea Extract,Fullerene, Collagen Peptide, Pro-Xylane,Tri(Cetearyl-4) Phosphate, AluminumHydroxide, Stearic Acid, Tocopheryl Acetate,

Natural Bisabolol

Section 51945-4 (51945-4)

GREEN TEAHydraShield SPF 50MoisturizerHIGH PROTECTIONUVA UVB PA++++

DRUG FACTTS

Active Ingredients Purpose

Zinc Oxide .. 6.0% . SunscreenTitanium Dioxide . 4.5%.Sunscreen

USES:

Helps prevent sunburn, If used as directed withother sun protection measures (see Directions),it helps minimize signs of UV-induced skin

aging

WARNINGS:

For external use only. Avoid contact with eyes.Discontinue use if irritation occurs. Keep out ofreach of children. If swallowed, get medicalhelp or contact a Poison Control Center right

away



OTHER INFORMATIONStore at 15-40°C(59-104°F).Keep containertightly closed and avoid extreme heat or directsun exposure.

INACTIVE INGREDIENTS:

Water, Ethylhexyl Palmitate, CetylEthylhexanoate, Tinosorb S (Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine),Butyloctyl Salicylate, PentaerythritylTetraethylhexanoate, Potassium Cetyl

Phosphate, Cetearyl Alcohol, Hemisqualane,Silica, Glyceryl Stearate, Sodium PCA,Panthenol, Niacinamide, Ascorbyl Glucoside,Sodium Hyaluronate, Acetylated SodiumHyaluronate, Cross-linked Sodium Hyaluronate,Hydrolyzed Sodium Hyaluronate, PolypodiumLeucotomos Extract, Green Tea Extract,Fullerene, Collagen Peptide, Pro-Xylane,Tri(Cetearyl-4)Phosphate, AluminumHydroxide, Stearic Acid, Tocopheryl Acetate,

Natural Bisabolol

Section 55105-1 (55105-1)



HIGH PROTECTION

UVA UVB PA++++

Section 55106-9 (55106-9)



Active Ingredients Purpose

Zinc Oxide . 6.0% … .SunscreenTitanium Dioxide .... 4.5%sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:05.909215 · Updated: 2026-03-14T23:13:23.763125