Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (0.0255 g) Zinc Oxide (0.03 g)

Inactive Ingredients

Water Sunflower Oil Glycerin Carthamus Tinctorius Seed Oleosomes Castor Oil Coconut Oil Medium-chain Triglycerides Cetearyl Glucoside Sucrose Distearate Royal Jelly Sucrose Stearate Acacia Calendula Officinalis Flower Hamamelis Virginiana Top Goldenseal Comfrey Root Xanthan Gum Lecithin, Soybean Polyhydroxystearic Acid (2300 Mw) Stearic Acid Aluminum Oxide Citric Acid Monohydrate Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-04-05

Medication Information

Purpose

SUNSCREEN, SUNSCREEN

Description

TITANIUM DIOXIDE 2.55%, ZINC OXIDE 3.00%

Use(s)

HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Warnings

FOR EXTERNAL USE ONLY.

Directions

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: 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.

Do Not Use

ON DAMAGED OR BROKEN SKIN.

Label Copy

Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Active Ingredients

TITANIUM DIOXIDE 2.55%, ZINC OXIDE 3.00%

Inactive Ingredients:

WATER (AQUA), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, CARTHAMUS TINCTORUS (SAFFLOWER) OLEOSOMES, RICINUS COMMUNIS (CASTOR) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL GLUCOSIDE, SUCROSE DISTEARATE, ROYAL JELLY, SUCROSE STEARATE, ACACIA SENEGAL GUM, CALENDULA OFFICINALIS FLOWER EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SYMPHYTUM OFFICINALE ROOT EXTRACT, XANTHAN GUM, LECITHIN, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ALUMINA, CITRIC ACID, NATURAL FRAGRANCE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN.

When Using This Product

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If

RASH OCCURS.

Structured Label Content

Use(s) (USE(S))

HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

Purpose (PURPOSE)

SUNSCREEN, SUNSCREEN

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: 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.

Do Not Use (DO NOT USE)

ON DAMAGED OR BROKEN SKIN.

Label Copy (LABEL COPY)

Other Information (OTHER INFORMATION)

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Active Ingredients (ACTIVE INGREDIENTS)

TITANIUM DIOXIDE 2.55%, ZINC OXIDE 3.00%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, CARTHAMUS TINCTORUS (SAFFLOWER) OLEOSOMES, RICINUS COMMUNIS (CASTOR) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL GLUCOSIDE, SUCROSE DISTEARATE, ROYAL JELLY, SUCROSE STEARATE, ACACIA SENEGAL GUM, CALENDULA OFFICINALIS FLOWER EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SYMPHYTUM OFFICINALE ROOT EXTRACT, XANTHAN GUM, LECITHIN, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ALUMINA, CITRIC ACID, NATURAL FRAGRANCE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN.

When Using This Product (WHEN USING THIS PRODUCT)

KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

RASH OCCURS.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USE(S)": "HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.", "PURPOSE": "SUNSCREEN, SUNSCREEN", "WARNINGS": "FOR EXTERNAL USE ONLY.", "DIRECTIONS": "APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. CHILDREN UNDER 6 MONTHS: 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.", "DO NOT USE": "ON DAMAGED OR BROKEN SKIN.", "OTHER INFORMATION": "PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.", "ACTIVE INGREDIENTS": "TITANIUM DIOXIDE 2.55%, ZINC OXIDE 3.00%", "INACTIVE INGREDIENTS:": "WATER (AQUA), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, CARTHAMUS TINCTORUS (SAFFLOWER) OLEOSOMES, RICINUS COMMUNIS (CASTOR) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL GLUCOSIDE, SUCROSE DISTEARATE, ROYAL JELLY, SUCROSE STEARATE, ACACIA SENEGAL GUM, CALENDULA OFFICINALIS FLOWER EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SYMPHYTUM OFFICINALE ROOT EXTRACT, XANTHAN GUM, LECITHIN, POLYHYDROXYSTEARIC ACID, STEARIC ACID, ALUMINA, CITRIC ACID, NATURAL FRAGRANCE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN.", "WHEN USING THIS PRODUCT": "KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.", "KEEP OUT OF REACH OF CHILDREN": "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.", "STOP USING THIS PRODUCT AND ASK A DOCTOR IF": "RASH OCCURS."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information