LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20- avobenzone, homosalate, octisalate and octocrylene cream

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by Charlotte Tilbury Beauty Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Drug Facts

ACTIVE INGREDIENT

PURPOSE

Active Ingredients                     Purpose

Avobenzone:   3%                       Sunscreen

Homosalate:  10%                      Sunscreen

Octisalate:      5%                       Sunscreen

Octocrylene:  10%                      Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water
to remove.

STOP USE

Stop use and ask a doctor if rash occurs

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.

Directions

apply liberally and evenly 15 minutes before sun exposure
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 time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
use a water-resistant sunscreen if swimming or sweating
reapply:
  at least every 2 hours
  immediately after towel drying

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Butylene Glycol, Coconut Alkanes, Glycerin, Silica, Crambe Abyssinica Seed Oil, Cetyl Alcohol, Glyceryl Stearate, Caprylyl Methicone, Potassium Cetyl Phosphate, PEG-75 Stearate, Dimethyl Isosorbide, Polysorbate 20, Phenoxyethanol, Hydroxyacetophenone, Marrubium Vulgare Extract, Ceteth-20, Steareth-20, Coco-Caprylate/Caprate, Xanthan Gum, Carbomer, Disodium EDTA, Rosa Damascena Extract, Ethylhexylglycerin, Sodium Hydroxide, Beta-Carotene, Tocopherol, Xanthophylls, Michelia Alba Leaf Oil, Citric Acid, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solanum Tuberosum Pulp Extract, Acetyl Tetrapeptide-11, Acetyl Tetrapeptide-9, Linalool, Citronellol, Geraniol.

OTHER INFORMATION

protect the product in this container from excessive heat and direct sun

Principal Display Panel - 5 mL 0.16 FL. OZ.

LIGHTWEIGHT,

MIRACLE MOISTURIZER

SUNSCREEN BROAD SPECTRUM SPF 20

5 mL e 0.16 FL. OZ.

Principal Display Panel - 15 mL 0.48 FL. OZ.

LIGHTWEIGHT,

MIRACLE MOISTURIZER

SUNSCREEN BROAD SPECTRUM SPF 20

15 mL e 0.48 FL. OZ.

Principal Display Panel - 50 mL 1.6 FL. OZ.

LIGHTWEIGHT,

MIRACLE MOISTURIZER

SUNSCREEN BROAD SPECTRUM SPF 20

50 mL e 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 
avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70186-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.525 g  in 5 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.525 g  in 5 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.263 g  in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.158 g  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCONUT ALKANES (UNII: 1E5KJY107T)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PEG-75 STEARATE (UNII: OT38R0N74H)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HOREHOUND (UNII: K08036XEJV)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BETA CAROTENE (UNII: 01YAE03M7J)
TOCOPHEROL (UNII: R0ZB2556P8)
LUTEIN (UNII: X72A60C9MT)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
POTATO PULP (UNII: 844I2DX0IS)
ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)
ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70186-600-01	1 in 1 CARTON	06/01/2020
1		5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 70186-600-02	1 in 1 CARTON	06/01/2020
2		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 70186-600-03	1 in 1 CARTON	06/01/2020
3		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2020

Labeler - Charlotte Tilbury Beauty Ltd. (218353520)