Buttah- Tinted Mineral Sunscreen 82069-102

Buttah- Tinted Mineral Sunscreen 82069-102
SPL v1
SPL
SPL Set ID 43458152-0775-dd9c-e063-6394a90a6140
Route
TOPICAL
Published
Effective Date 2021-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (6 g) Titanium Dioxide (2.5 g)
Inactive Ingredients
Water Medium-chain Triglycerides Cyclomethicone 5 Propanediol Dimethicone Glycerin Alkyl (c12-15) Benzoate Peg-100 Stearate Glyceryl Monostearate Cetyl Alcohol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Glyceryl Caprylate Cyclomethicone 6 Sucrose Cocoate Anhydrous Citric Acid Sodium Citrate Sodium Pyrrolidone Carboxylate Glyceryl Isostearate Aluminum Oxide Caprylyl Trisiloxane Polyhydroxystearic Acid (2300 Mw) Dimethicone 100 Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Chlorphenesin Ferric Oxide Red Ferric Oxide Yellow Allantoin Xanthan Gum Green Tea Leaf Matricaria Recutita Flowering Top Cucumber Glyceryl 1-undecylenate Panthenol Fytic Acid Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-13

Description

TITANIUM DIOXIDE 2.5% ZINC OXIDE 6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

TITANIUM DIOXIDE 2.5% ZINC OXIDE 6%

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 sun
Section 44425-7

CALL TOLL FREE:  1-800-428-8824

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGE 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.

Directions
  • APPLY LIBERALLY 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
  •      LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM.
  •      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
  •      CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Active Ingredients

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6%

Inactive Ingredients

Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.

Questions Or Comments
  • call toll free:  1-833-428-8824

Structured Label Content

Uses (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 sun
Section 44425-7 (44425-7)

CALL TOLL FREE:  1-800-428-8824

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGE 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.

Directions (DIRECTIONS)
  • APPLY LIBERALLY 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
  •      LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM.
  •      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
  •      CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Active Ingredients (ACTIVE INGREDIENTS)

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.

Questions Or Comments (QUESTIONS OR COMMENTS)
  • call toll free:  1-833-428-8824

Advanced Ingredient Data


Raw Label Data

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