Sqn - Brighter Day Broad Spectrum Spf30 (82495-101)

Sqn - Brighter Day Broad Spectrum Spf30 (82495-101)
SPL v1
SPL
SPL Set ID d4dc1f89-7433-ae35-e053-2a95a90a5bfa
Route
TOPICAL
Published
Effective Date 2022-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (10 g)
Inactive Ingredients
Diethylhexyl 2,6-naphthalate Tocopherol Ethylhexylglycerin Water Medium-chain Triglycerides Dimethicone Butylene Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Sodium Oleate Xylitylglucoside Anhydroxylitol Xylitol Pentylene Glycol Phenoxyethanol Anhydrous Citric Acid Ferric Oxide Red Tea Leaf Oil Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-12-20

Description

ZINC OXIDE

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE

Use

HELPS PREVENT SUNBURN

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 51945-4

Warnings

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.

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

  • SUN PROTECTION MEASURES.

    SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE 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 10:00 A.M. - 2 P.M.
  • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Active Ingredient

ZINC OXIDE

Other Information
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Inactive Ingredients

WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIETHYLHEXYL 2,6-NAPHTHALATE, HYDROXYETHYL ACRYLATE/SODIUM, ACRYLOYLDIMETHYL TAURATE COPOLYMER, SODIUM OLIVATE, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, TRIETHOXYCAPRYLYLSILANE, XYLITOL,PENTYLENE GLYCOL, CITRIC ACID, TOCOPHEROL, CAMELLIA SINENSIS LEAF OIL, DIMETHICONE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, IRON OXIDES.


Structured Label Content

Use (USE)

HELPS PREVENT SUNBURN

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

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.

Directions (DIRECTIONS)
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • REAPPLY AT LEAST EVERY 2 HOURS.

  • SUN PROTECTION MEASURES.

    SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY AGING. TO DECREASE THE 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 10:00 A.M. - 2 P.M.
  • WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE

Other Information (OTHER INFORMATION)
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIETHYLHEXYL 2,6-NAPHTHALATE, HYDROXYETHYL ACRYLATE/SODIUM, ACRYLOYLDIMETHYL TAURATE COPOLYMER, SODIUM OLIVATE, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, TRIETHOXYCAPRYLYLSILANE, XYLITOL,PENTYLENE GLYCOL, CITRIC ACID, TOCOPHEROL, CAMELLIA SINENSIS LEAF OIL, DIMETHICONE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, IRON OXIDES.


Advanced Ingredient Data


Raw Label Data

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