C LIP SERUM MINERAL BROAD SPECTRUM SPF 30- sunscreen gel

C Lip Serum Mineral Broad Spectrum SPF 30 by

Drug Labeling and Warnings

C Lip Serum Mineral Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Simply Active Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 16.5% … Sunscreen

PURPOSE

Sunscreen

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

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

INSTRUCTIONS FOR USE

Apply lip serum generously and evenly
Reapply at least every 2 hours throughout the day as needed
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: 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 your time in the sun, especially from 10 a.m. to 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Water, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, C12-15 Alkyl Benzoate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Poly(C6-14 Olefin), Mica, Glyceryl Dibehenate, Flavor, Microcrystalline Cellulose, Tribehenin, Polyglyceryl-3 Diisostearate, Microcrystalline Wax, Cellulose Gum, Synthetic Fluorphlogopite, Glyceryl Behenate, Lecithin, Caprylyl Glycol, Sodium Chloride, Citric Acid, Ethylhexylglycerin, Polyglyceryl-4 Oleate, Sodium Citrate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Limonene, Titanium Dioxide (CI 77891), Red 7 Lake (CI 15850)

INDICATIONS & 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.

DOSAGE & ADMINISTRATION

Apply lip serum generously and evenly

Apply liberally 15 minutes before sun exposure

Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Children under 6 months of age: Ask a doctor

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-11

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Drug Facts

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10 g NDC: 83302-165-11

Outer Carton Front Panel

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Side Panel 1

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Side Panel 2

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-11

Outer Carton Drug Facts Cont Side Panel 1

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-10

Pink Primary

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-10

Pink- Outer Carton Drug Facts Cont

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-10

Pink Outer Drug Facts Panel

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-10

Pink Outer Front Panel

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-10

Outer Pink Side Panel 1

PRINCIPAL DISPLAY PANEL

0.35 FL. OZ. 10g NDC: 83302-165-10

Pink Outer Side Panel 2

INGREDIENTS AND APPEARANCE

C LIP SERUM MINERAL BROAD SPECTRUM SPF 30 
sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83302-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MORINGA OLEIFERA SEED (UNII: TIX5482832)
C9-12 ALKANE (UNII: 7J5R5W72QM)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BIS-BEHENYL/ISOSTEARYL/PHYTOSTERYL DIMER DILINOLEYL DIMER DILINOLEATE (UNII: G27BTQ95MJ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CI 77491 (UNII: 1K09F3G675)
AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
PIGMENT BLUE 1 (UNII: 4SBE571RQF)
PIGMENT RED 7 (UNII: 5Z5A89AQ44)
YELLOW 5 (UNII: I753WB2F1M)
TRITICUM VULGARE (WHEAT) GERM OIL (UNII: 14C97E680P)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
CI 77492 (UNII: EX438O2MRT)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
HYDROGENATED POLYISOBUTENE (450 MW) (UNII: 7YR4ZFS62E)
SORBITAN LAURATE (UNII: 6W9PS8B71J)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ZEA MAYS (CORN) OIL (UNII: 8470G57WFM)
CITRUS AURANTIUM PEEL OIL (UNII: 9TLV70SV6I)
POLYGLYCEROL POLYRICINOLEIC ACID (UNII: 3C96Y1D5T4)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)
CI 77499 (UNII: XM0M87F357)
RED 27 (UNII: 2LRS185U6K)
RED 28 (UNII: 767IP0Y5NH)
RED 6 (UNII: 481744AI4O)
CI 77891 (UNII: 15FIX9V2JP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EUPHORBIA CERIFERA (CANDELILLA) WAX (UNII: WL0328HX19)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
N-ACETYL-.ALPHA.-D-GLUCOSAMINE (UNII: T13TI5GH3D)
VANILLIN (UNII: CHI530446X)
TOCOPHEROL (UNII: R0ZB2556P8)
HORDEUM VULGARE TOP (UNII: 86507VZR9K)

Product Characteristics
Color	pink, orange (Neutral Peach)	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83302-165-10	1 in 1 BOX	05/01/2025
1		10 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 83302-165-11	1 in 1 BOX	05/01/2025
2		10 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	05/01/2025

Labeler - Simply Active Cosmetics (116908845)

Registrant - Simply Active Cosmetics (116908845)

Establishment
Name	Address	ID/FEI	Business Operations
Simply Active Cosmetics		116908845	label(83302-165)