TINTED LIP SHIELD- zinc oxide and homosalate cream

Tinted Lip Shield by

Drug Labeling and Warnings

Tinted Lip Shield by is a Otc medication manufactured, distributed, or labeled by OneKind.25. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 8 %

Zinc Oxide 5.6 %

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Indication & Usage

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.

WARNINGS

Warnings

Do not use on damaged or
broken skin.

DO NOT USE

Do not use on damaged or
broken skin.

WHEN USING

When using this product keep out of eyes

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help
or contact a poison control center right away

DOSAGE & ADMINISTRATION

Directions Apply generously
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 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

OTHER SAFETY INFORMATION

Protect the product in this
container from excessive heat
and direct sun.

INACTIVE INGREDIENT

Inactive Ingredients
helianthus annuus (sunflower)
seed oil, ricinus communis
(castor) seed oil, cocos nucifera
(coconut) oil, polyhydroxystearic
acid, simmondsia chinensis
(jojoba) seed oil, euphorbia
cerifera (candelilla) wax,
butyrospermum parkii (shea) nut
extract, squalane, jojoba esters,
rhus verniciflua peel wax,
caprylic/capric triglyceride,
polyglyceryl-3 polyricinoleate,
isostearic acid, lecithin, ascorbyl
palmitate, glycerin, averrhoa
carambola fruit extract,
tocopherol, octyldodecanol,
sorbitan oleate, alumina,
magnesium oxide, flavor.
may contain (+/-): ci 77491 (iron
oxides), ci 77492 (iron oxides),
ci 77499 (iron oxides)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TINTED LIP SHIELD 
zinc oxide and homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79356-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.6 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEANUT (UNII: 84H6HBP32L)
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
GLYCERIN (UNII: PDC6A3C0OX)
STAR FRUIT (UNII: G00N2E9394)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECANOL (UNII: 461N1O614Y)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
CANDELILLA WAX (UNII: WL0328HX19)
SQUALANE (UNII: GW89575KF9)
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX (UNII: 6RG2461FCH)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79356-203-02	1 in 1 CARTON	03/25/2022
1	NDC: 79356-203-01	8.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/25/2022

Labeler - OneKind.25 (080286020)