Zinc Five-o Zinxation Baby Mineral Sunscreen Spf-50

Zinc Five-o Zinxation Baby Mineral Sunscreen Spf-50
SPL v7
SPL
SPL Set ID b3199cf4-eb90-68c2-e053-2a95a90a8a29
Route
TOPICAL
Published
Effective Date 2020-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (25 g)
Inactive Ingredients
Water Coco-caprylate/caprate Glycerin Coconut Alkanes Jojoba Oil Polyglyceryl-3 Ricinoleate Yellow Wax Isostearic Acid Polyhydroxystearic Acid (2300 Mw) Maltodextrin Aloe Vera Leaf Phenylpropanol Propanediol Caprylyl Glycol Tocopherol Ethylhexylglycerin Cetyl Phosphate Sodium Chloride Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-11-02

Description

ZINC OXIDE 25%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 25%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun
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.

Questions?
Directions:
  • APPLY LIBERALLY AND EVENLY 20 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY:
  •    AFTER 40 MINUTES OF SWIMMING OR SWEATING
  •    IMMEDIATELY AFTER TOWEL DRYING
  •    AT LEAST EVERY 2 HOURS
  • 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
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Active Ingredient

ZINC OXIDE 25%

Other Information

STORE AT TEMPERATURES BELOW 90°F (30°C). PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients

Water, Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, Aloe Barbadensis Leaf Extract, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA


Structured Label Content

Uses (USES)
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun
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.

Questions? (QUESTIONS?)
Directions: (DIRECTIONS:)
  • APPLY LIBERALLY AND EVENLY 20 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY:
  •    AFTER 40 MINUTES OF SWIMMING OR SWEATING
  •    IMMEDIATELY AFTER TOWEL DRYING
  •    AT LEAST EVERY 2 HOURS
  • 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
  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 25%

Other Information (OTHER INFORMATION)

STORE AT TEMPERATURES BELOW 90°F (30°C). PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, Aloe Barbadensis Leaf Extract, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA


Advanced Ingredient Data


Raw Label Data

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