RITUALS MIRACLE LIGHT WEIGHT FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN. - WARM BEIGE- octinoxate, titanium dioxide cream

RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Warm Beige by

Drug Labeling and Warnings

RITUALS Miracle Light Weight Foundation broad spectrum SPF 15 sunscreen. - Warm Beige by is a Otc medication manufactured, distributed, or labeled by Rituals Cosmetics USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

OCTINOXATE 6.00%
TITANIUM DIOXIDE 2.42%

Purpose

Sunscreen

Use

• 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

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 Poison Control Center right away

Directions

For sunscreen use

• Apply liberally 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
• Children under 6 months months of age: Ask a doctor

Other Information

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

Inactive ingredients

AQUA/WATER, PHENYL TRIMETHICONE, DICAPRYLYL ETHER, CAPRYLIC/CAPRIC TRIGLYCERIDE, DISILOXANE, TALC, TRIMETHYLSILOXYSILICATE,
DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, CETYL PEG/PPG-10/1 DIMETHICONE, SODIUM CHLORIDE, ETHYLHEXYL PALMITATE, PHENOXYETHANOL, SILICA DIMETHYL SILYLATE, DISTEARDIMONIUM HECTORITE, SILICA, SODIUM DEHYDROACETATE, DIETHYLHEXYL
SYRINGYLIDENEMALONATE, METHICONE, BENZYL ALCOHOL, TREHALOSE, SPILANTHES ACMELLA FLOWER EXTRACT, TRIHYDROXYSTEARIN,
AMETHYST POWDER, MALACHITE, SAPPHIRE POWDER, BHT,  SODIUM HYALURONATE, AMORPHOPHALLUS KONJAC ROOT POWDER +/- (MAY CONTAIN) CI 77891 (TITANIUM DIOXIDE) CI 77492 (IRON OXIDES) CI 77491(IRON OXIDES) CI 77499 (IRON OXIDES).

Questions or comments?

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Package Labeling:

INGREDIENTS AND APPEARANCE

RITUALS MIRACLE LIGHT WEIGHT FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN. - WARM BEIGE 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57525-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
METHICONE (20 CST) (UNII: 6777U11MKT)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TREHALOSE (UNII: B8WCK70T7I)
ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57525-040-30	1 in 1 BOX	01/29/2018
1		30 mL in 1 BOTTLE; 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	01/29/2018

Labeler - Rituals Cosmetics USA, Inc. (078749583)